i-STAT 03P84-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10054749000125), received between Mar 17, 2017 and Apr 11, 2023 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (29 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K973292); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 24, 2025Open, Classified

   transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

   Z-1846-2025 · Root cause: Storage · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 29-MAR-2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULTS ON A 75 YEAR OLD MALE PATIENT PRESENTED FOR A 6 MONTH CANCER FOLLOW UP. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16716841 ↗
• MalfunctionFeb 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 02-FEB-2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULTS ON A 75 YEAR OLD FEMALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, DRAWN: 15:05, RESULT: 2.6 MG/DL, SAMPLE: WB; I-STAT, 15:24, 2.4 MG/DL, WB; ROCHE COBAS, 16:03, 1.8 MG/DL, PLASMA. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16325907 ↗
• MalfunctionSep 15, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT CREATININE RESULT OF <0.2 MG/DL ON A 50 YEAR OLD MALE PATIENT WITH ABDOMINAL PAIN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE CUSTOMER ALSO REPORTS THAT THE PATIENT WAS GIVEN CONTRAST BASED ON ONE I-STAT RESULT OF <0.2 MG/DL. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Abdominal Pain

  MAUDE report 15427829 ↗
• MalfunctionAug 23, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 09-AUG-2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT CREATININE RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. (B)(6). TEST/COLLECTION TIMES NOT PROVIDED. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE CUSTOMER HAS NOT PROVIDED PRODUCT LOT INFORMATION. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15279056 ↗
• MalfunctionAug 2, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULTS A 75 YEAR OLD FEMALE DIABETIC PATIENT FOR FOLLOW UP TESTING. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (METHOD, DATE, TESTED, RESULT, SAMPLE, COLLECTION) I-STAT, (B)(6) 22, 10:21, 4.6 MG/DL, A, WHOLE BLOOD IN LI-HEPARIN SYRINGE; I-STAT, (B)(6) 22, 11:13, 3.5 MG/DL, A, WHOLE BLOOD IN LI-HEPARIN SYRINGE; I-STAT, (B)(6) 22, 12:00, 3.5 MG/DL, A, WHOLE BLOOD IN LI-HEPARIN SYRINGE; COBAS C501, (B)(6) 22, N/A, 0.57 MG/DL, A, PLASMA SEPARATED FROM LI-HEPARIN TUBE; COBAS C501, (B)(6) 22, N/A, 0.56 MG/DL, A, PLASMA, EDTA SYRINGE; COBAS C501 (B)(6) 22 N/A, 0.65 MG/DL, B, N/A. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15146215 ↗
• MalfunctionFeb 1, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULT OF 3.17 MG/DL ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD; DATE; COLLECTED; TESTED; CREA (MG/DL); SAMPLE: ALINITY; (B)(6) 2022; NI; 11:42; 3.17; VENOUS WHOLE BLOOD. I-STAT; (B)(6) 2022; 12:18; 12:23; 2.0; VENOUS WHOLE BLOOD. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13415718 ↗
• MalfunctionJan 5, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULT OF 4.0 MG/DL ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. (B)(6). TEST/COLLECTION TIMES NOT PROVIDED. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. PATIENT MEDICATION WAS REQUESTED AS IT IS SUSPECTED THAT PATIENT MAY BE TAKING HYDROXYUREA. I-STAT RESULTS CAN BE HIGHER THAN NORMAL WITH THE USE OF HYDROXYUREA, A SUBSTANCE THAT IS KNOWN TO INTERFERE WITH THE I-STAT CREATININE ASSAY. REFER TO ART: 714183-00 REV AA. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13170128 ↗
• MalfunctionAug 10, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT CREATININE RESULTS OF 0.8 AND 0.7 ON AN (B)(6) YEAR OLD FEMALE PATIENT PRESENTED WITH MALIGNANT NEOPLASM. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304965 ↗
• MalfunctionJun 29, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084227 ↗
• MalfunctionMay 11, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 23-APR-2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULTS ON AN (B)(6) YEAR OLD FEMALE CANCER PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. IT IS SUSPECTED THAT THE CAUSE FOR ELEVATED RESULTS IS DUE TO PATIENT USING HYDROXYUREA. HOWEVER, PATIENT MEDICATION WAS REQUESTED BUT NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER STATES THE PATIENT IS AN ONCOLOGY PATIENT WHO IS CURRENTLY UNDER TREATMENT., AND SUSPECTS THERE WAS A DRUG INTERFERENCE RELATED TO THIS SITUATION. HYDROXYUREA IS SUSPECTED BUT NOT CONFIRMED AT THE TIME OF THIS REPORT. PER THE I-STAT CREA CARTRIDGE - REF 03P84-25 ART: 765791-00 REV. B., HYDROXYUREA WILL INCREASE CREA RESULT. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Cancer

  MAUDE report 11807200 ↗
• MalfunctionFeb 16, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 01-FEB-2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULT OF 2.8 MG/DL ON A (B)(6) YEAR OLD FEMALE PATIENT PRESENTED WITH PAIN, POST-OP HYSTERECTOMY. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD:I-STAT. DATE: (B)(6) 2021. COLLECTED: 1530. TESTED: 153. RESULT: 2.8 MG/DL. SAMPLE:VENOUS. METHOD : (B)(6). DATE : (B)(6) 2021. COLLECTED : NI. TESTED :NI . RESULT : 1.2 MG/DL . SAMPLE: NI. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Pain

  MAUDE report 11334305 ↗
• MalfunctionJun 10, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULT OF 230 UMOL/L ON A PATIENT. THE CUSTOMER STATED THAT 230 UMOL/L WAS UNEXPECTED AS THE PATIENT HAD A NORMAL EGFR JUST A FEW WEEKS AGO (APPROXIMATELY 80). THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). THE SAME SAMPLE WAS TESTED ON ONE OF THE CARDIAC CT I-STAT 1 ANALYZER, AS WELL AS THE CT I-STAT, 1 ANALYZER FROM PATHOLOGY. ONCE AGAIN BOTH RESULTS CAME IN AROUND 220 UMOL/L. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE CUSTOMER WAS ADVISED THAT USING A SERUM SPECIMEN IS OUTSIDE OF THE INTENDED USE (OFF-LABEL) FOR THE I-STAT CREATININE TEST. REFERENCE: CARTRIDGE AND TEST INFORMATION (CTI) ART (B)(4). THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Information

  MAUDE report 10138302 ↗
• MalfunctionApr 21, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULT OF 0.6MG/DL ON A (B)(6) YEAR OLD FEMALE PATIENT WITH BLOOD IN URINE. THERE WAS ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, DATE: (B)(6) 2020, COLLECTED: 13:30, TESTED: 13:30, RESULT: 2.6MG/DL, SAMPLE: A. I-STAT, (B)(6) 2020, 13:35, 13:35, 0.6MG/DL, A. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. ON (B)(6) 2020 THE CUSTOMER CONTACTED APOC STATING THAT ANALYZER SN (B)(4) BE REPLACED DUE TO THE I-STAT GENERATED DISCREPANT PATIENT RESULTS. ANALYZER SN (B)(4) WILL BE INVESTIGATED SEPARATELY UNDER APOC INCIDENT (B)(4). MEDICATIONS WERE NOT PROVIDED. HOWEVER, THE CUSTOMER CONFIRMED THE PATIENT WAS NOT ON HYDROXYUREA. A SUBSTANCE THAT IS KNOWN TO INTERFERE WITH THE I-STAT CREATININE ASSAY. REFER TO ART: (B)(4) REV AA. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS U

  Patient problems: Hematuria

  MAUDE report 9982179 ↗
• MalfunctionNov 26, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: No Information

  MAUDE report 9377112 ↗
• MalfunctionAug 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: Cancer

  MAUDE report 8915103 ↗
• MalfunctionAug 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: Abdominal Pain

  MAUDE report 8915102 ↗
• MalfunctionJul 3, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 06/17/2019, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. NOR WAS THERE PRODUCT LOT INFORMATION. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THERE IS NO PATIENT INFORMATION, PRODUCT LOT, AND THE ER RESULT OF 0.78 IS ONLY INFORMATION GIVEN AND COULD NOT BE CONFIRMED. WITH MULTIPLE ATTEMPTS TO OBTAIN INFORMATION, THE CUSTOMER IS NOT RESPONDING TO REQUESTS. THE RESULTS WERE REVIEWED AND DETERMINED THAT THE I-STAT RESULTS WERE HIGHER THAN NORMAL BUT WERE FOUND TO BE CONSISTENT WITH THE USE OF HYDROXYUREA, A SUBSTANCE THAT IS KNOWN TO INTERFERE WITH THE I-STAT CREATININE ASSAY. HOWEVER, THIS COULD NOT BE CONFIRMED. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Information

  MAUDE report 8759893 ↗
• MalfunctionJun 5, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2019, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULTS ON A FEMALE PATIENT PRESENTED FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE I-STAT RESULTS WERE CONSISTENT AT WITH TWO DIFFERENT SAMPLES WHILE THE ALTERNATE METHOD WAS CONSISTENT WITH ITS REPEAT ON THE SAME SAMPLE. THERE WAS NO PATIENT INFORMATION OR MEDICATIONS PROVIDED. IT IS SUSPECTED THAT THE PATIENT IS ON HYDROXYUREA, A SUBSTANCE THAT IS KNOWN TO INTERFERE WITH THE I-STAT CREATININE ASSAY. HOWEVER, THIS COULD NOT BE CONFIRMED AT THE TIME OF THIS REPORT. REFER TO I-STAT SYSTEM MANUAL, ART: 714183-00 REV AA. THE REPORTING DECISION WAS BASED ON INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Code Available

  MAUDE report 8670738 ↗
• MalfunctionMay 16, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2019, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULTS ON A (B)(6) YEAR OLD FEMALE PATIENT WITH PERIPHERAL VASCULAR DISEASE WITH CLAUDICATION. BOTH I-STAT RESULTS WERE CONSISTENT AT 2.4 MG/DL FROM A VENOUS LINE. A REPEAT ON THE ALTERNATE METHOD WAS 0.5 MG/DL VIA VENIPUNCTURE. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Claudication; Peripheral Vascular Disease

  MAUDE report 8615333 ↗
• MalfunctionMay 7, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2019, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THERE WAS NO PATIENT INFORMATION. THE CUSTOMER STATED THAT THE PATIENT WAS ADMITTED IN VIEW OF AKI DUE TO SUDDEN INCREASE OF CREATININE RESULT AND POSTPONED CT UROGRAM DUE TO FALSELY HIGH CREATININE RESULT. THE CUSTOMER REPORTS THAT THERE WAS NO IMPACT TO PATIENT CARE AND THE CT UROGRAM WAS NOT PERFORMED. THE PATIENT WAS NOT TREATED ON I-STAT. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Hematuria

  MAUDE report 8587288 ↗
• MalfunctionOct 24, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2018, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULT ON AN (B)(6) YEAR OLD MALE CANCER PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). TEST AND SAMPLE COLLECTION TIMES WERE NOT PROVIDED. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. BASED ON THE I-STAT RESULTS IT IS SUSPECTED THAT THE PATIENT WAS TAKING HYDROXYUREA ALTHOUGH THE CUSTOMER REPORTED THAT HYDROXYUREA WAS NOT LISTED ON MEDICATION LIST. THE ORDERING DOCTOR STATED THAT THE PATIENT WAS ON HYDROXYUREA BACK IN (B)(6) 2018 BUT NOT NOW.

  Patient problems: Cancer

  MAUDE report 8001409 ↗
• MalfunctionSep 13, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2018, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULT ON A FEMALE PATIENT CANCER PATIENT WHO WAS RECEIVING CHEMOTHERAPY TREATMENTS THE WEEK OF (B)(6) 2018.. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Apnea; Breast Cancer; Transient Ischemic Attack

  MAUDE report 7872287 ↗
• MalfunctionSep 6, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2018, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULT ON A (B)(6) MALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Information

  MAUDE report 7850120 ↗
• MalfunctionApr 26, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2018, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULT ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. APOC SUSPECTS THAT THE HIGH RESULTS ARE BECAUSE THE USE OF HYDROXYUREA. HOWEVER THIS IS NOT CONFIRMED AT THIS TIME. THE CUSTOMER STATES THAT THEY DO NOT HAVE VISIBILITY TO THAT INFORMATION AND THEY HAVE PROVIDED ALL THE INFORMATION THAT THEY ARE ABLE TO. PER I-STAT SYSTEM MANUAL, ART: 714183-00Y. REV. DATE: 15-JUL-16: HYDROXYUREA IS A DNA SYNTHESIS INHIBITOR USED IN THE TREATMENT OF VARIOUS FORMS OF CANCER, SICKLE CELL ANEMIA, AND HIV INFECTION. THIS DRUG IS USED TO TREAT MALIGNANCIES INCLUDING MELANOMA, METASTATIC OVARIAN CANCER, AND CHRONIC MYELOGENOUS LEUKEMIA. IT IS ALSO USED IN THE TREATMENT OF POLYCYTHEMIA VERA, THROMBOCYTHEMIA, AND PSORIASIS. AT TYPICAL DOSES RANGING FROM 500 MG TO 2 G/DAY, CONCENTRATIONS OF HYDROXYUREA IN PATIENTS' BLOOD MAY BE SUSTAINED AT APPROXIMATELY 100 TO 50

  Patient problems: No Information

  MAUDE report 7463826 ↗
• MalfunctionApr 26, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2018, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULT ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE. (B)(6). COLLECTION AND TEST TIMES ARE UNKNOWN. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. APOC SUSPECTS THAT THE HIGH RESULTS ARE BECAUSE THE USE OF HYDROXYUREA. HOWEVER THIS IS NOT CONFIRMED AT THIS TIME. THE CUSTOMER STATES THAT THEY DO NOT HAVE VISIBILITY TO THAT INFORMATION AND THEY HAVE PROVIDED ALL THE INFORMATION THAT THEY ARE ABLE TO. PER I-STAT SYSTEM MANUAL, ART: 714183-00Y. REV. DATE: (B)(6) 2015: HYDROXYUREA IS A DNA SYNTHESIS INHIBITOR USED IN THE TREATMENT OF VARIOUS FORMS OF CANCER, SICKLE CELL ANEMIA, AND HIV INFECTION. THIS DRUG IS USED TO TREAT MALIGNANCIES INCLUDING MELANOMA, METASTATIC OVARIAN CANCER, AND CHRONIC MYELOGENOUS LEUKEMIA. IT IS ALSO USED IN THE TREATMENT OF POLYCYTHEMIA VERA, THROMBOCYTHEMIA, AND PSORIASIS. AT TYPICAL DOSES RANGING FROM 500 MG TO 2 G/DAY, CONCENTRATIONS OF HYDROXYUREA IN PATIENTS' BLOOD MA

  Patient problems: No Information

  MAUDE report 7463821 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K973292. One submission often covers many models, so check the product and lot details in each record.

• Z-0456-2011 · Mar 17, 2010 · Terminated
  i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc., Princeton, NJ.
• Z-0373-2008 · Oct 18, 2007 · Terminated
  Abbott Point of Care, i-STAT CREA Cartridge (Creatine/Crea); List No: 06F10-01; Part No: 320100; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.