i-STAT 06P23-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 195 adverse event reports that list this exact device (DI 10054749001986), received between May 20, 2017 and Jan 5, 2022 — classified as 195 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (124 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 195 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2022False Positive Result; False Positive Result

  ON (B)(6) 2021, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A DISCREPANT FALSE POSITIVE RESULTS OF 1.36 NG/ML ON A (B)(6) FEMALE PATIENT WITH CORONARY-MYOCARDIAL BRIDGE - PRIMARY; CHEST PAIN; CHEST PAIN AT REST; NAUSEA. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 714258-00U, REPORTABLE RANGE: 0.00 - 50.00, REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS), REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: Chest Pain; Nausea

  MAUDE report 13170135 ↗
• MalfunctionDec 15, 2020False Positive Result; False Positive Result

  ON (B)(6) 2020, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT FALSE POSITIVE RESULT OF 0.130 NG/L ON A PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED RESULT (UNIT): I-STAT (B)(6) 2020 2415 2419 0.00 NG/L, I-STAT (B)(6) 2020 0332 0337 130 NG/L, I-STAT (B)(6) 2020 0655 0701 0.00 NG/L, I-STAT (B)(6) 2020 0800 0808 0.00 NG/L. SAMPLES: HEPARIN TUBE WHOLE BLOOD. 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. PER I-STAT SYSTEM MANUAL: ART: 714258-00T, REPORTABLE RANGE: 0.00 - 50.00, REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS), REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: Chest Pain

  MAUDE report 11010919 ↗
• MalfunctionNov 18, 2020False Positive Result; False Positive Result

  ON 07-NOV-2020, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT FALSE POSITIVE RESULT OF 0.06 NG/ML ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. METHOD: DATE: TESTED RESULT: I-STAT; (B)(6) 2020; 14:00; 0.06. I-STAT (B)(6) 2020; NI; 0.00. SAMPLE COLLECTION/TEST TIMES NOT REPORTED FACILITY POSITIVE CUT-OFF VALUE FOR I-STAT TROPONIN TEST: 0.04. 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. PER I-STAT SYSTEM MANUAL: ART: 714258-00T; REPORTABLE RANGE: 0.00 - 50.00; REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS); REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10859685 ↗
• MalfunctionOct 28, 2020False Positive Result; False Positive Result

  ON 19-OCT-2020, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT FALSE POSITIVE RESULT OF 0.24 NG/ML ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. METHOD: DATE: RESULT: I-STAT; (B)(6) 2020; 0.24. I-STAT; (B)(6) 2020; 0.00. SAMPLE COLLECTION/TEST TIMES NOT REPORTED. 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. PER I-STAT SYSTEM MANUAL: ART: 714258-00T: REPORTABLE RANGE: 0.00 - 50.00; REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS); REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10748067 ↗
• MalfunctionOct 28, 2020False Positive Result; False Positive Result

  ON (B)(6) 2020, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT FALSE POSITIVE RESULT OF 0.28 NG/ML ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. METHOD: DATE: RESULT: I-STAT; (B)(6) 2020; 0.28. I-STAT; (B)(6) 2020; 0.00. SAMPLE COLLECTION/TEST TIMES NOT REPORTED. 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. PER I-STAT SYSTEM MANUAL: ART: 714258-00T. REPORTABLE RANGE: 0.00 - 50.00; REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS); REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10747994 ↗
• MalfunctionMay 20, 2020False Positive Result; False Positive Result

  ON (B)(6) 2020, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT FALSE POSITIVE RESULT OF 0.86 NG/ML ON A (B)(6) YEAR OLD MALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). POSITIVE CUT-OFF VALUE: I-STAT: >0.03 NG/ML. LAB: >0.03 NG/ML. 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. THERE IS NO EVIDENCE THAT THE PATIENT SUFFERED AN MI. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: (B)(4). REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: No Information

  MAUDE report 10074989 ↗
• MalfunctionApr 21, 2020False Positive Result; False Positive Result

  NA.

  Patient problems: Chest Pain

  MAUDE report 9982185 ↗
• MalfunctionJan 8, 2020False Positive Result; False Positive Result

  NA.

  Patient problems: No Information

  MAUDE report 9563936 ↗
• MalfunctionJan 8, 2020False Negative Result; False Negative Result

  ON (B)(6) 2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT FALSE NEGATIVE RESULTS OF 0.02 ON A (B)(6) YEAR OLD MALE PATIENT WITH CHEST PAIN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). 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. PER I-STAT SYSTEM MANUAL: ART: (B)(4). REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: Chest Pain

  MAUDE report 9563933 ↗
• MalfunctionDec 20, 2019False Negative Result; False Negative Result

  ON (B)(6) 2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT FALSE NEGATIVE RESULTS ON A (B)(6) YEAR OLD FEMALE PATIENT WITH ACUTE ISCHEMIC, HEART DISEASE, UNSPECIFIED NON-ST ELEVATION (NSTEMI) MYOCARDIAL INFARCTION. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. (B)(6). 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. PER I-STAT SYSTEM MANUAL: ART: 714258-00Q. REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: Ischemic Heart Disease; Myocardial Infarction; ST Segment Elevation

  MAUDE report 9506375 ↗
• MalfunctionDec 20, 2019False Positive Result; False Positive Result

  ON (B)(6) 2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT FALSE POSITIVE RESULTS ON A FEMALE PATIENT WITH CHEST PAIN RADIATING TO HER TEETH. THERE WAS NO ADDITIONAL PATIENT INFORMATION, DATE TIMES OF TESTING, OR PRODUCT LOT# AT THE TIME OF THIS REPORT. METHOD: I-STAT, RESULT: 0.34 NG/ML, SAMPLE: A, DAY: 1. LAB, <1.0, A, 1. I-STAT, 0.33 NG/ML, B, 2. LAB, <1.0, B, 2. 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. PER I-STAT SYSTEM MANUAL: ART: 714258-00Q. REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: No Information

  MAUDE report 9506366 ↗
• MalfunctionDec 20, 2019False Negative Result; False Negative Result

  ON (B)(6) 2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT FALSE NEGATIVE RESULTS ON A (B)(6) YEAR OLD MALE PATIENT WITH COUGH, CONGESTION, SHORTNESS OF BREATH, VOMITING, AND COPD. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). 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. PER I-STAT SYSTEM MANUAL: ART: 714258-00Q. REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD); Congestive Heart Failure; Respiratory Distress; Vomiting

  MAUDE report 9506362 ↗
• MalfunctionNov 13, 2019False Positive Result; False Positive Result

  ON (B)(6) 2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT TROPONIN RESULT OF 0.64 ON A (B)(6) YEAR OLD FEMALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, DATE: 10/24/2019, COLLECTED: 16:47, TESTED: 16:47, RESULT: 0.64NG/ML. LAB, 10/24/2019, 17:44, 17:44, <0.01NG/ML. LAB, 10/24/2019, 20:02, 20:02, <0.01NG/ML. 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. PER I-STAT SYSTEM MANUAL: ART: 714258-00Q. REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: No Information

  MAUDE report 9315260 ↗
• MalfunctionNov 6, 2019False Negative Result; False Negative Result

  ON (B)(6) 2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT TROPONIN RESULT OF 0.00 ON A (B)(6) YEAR OLD FEMALE PATIENT WITH CHEST PAIN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, DATE: 10/28/2019, COLLECTED: 09:37, TESTED: 09:44, RESULT: 2.51 UG/L, SAMPLE: A. I-STAT, 10/28/2019, 15:40, 15:55, 0.00 UG/L, B. I-STAT, 10/28/2019, 15:40, 16:07, 3.24 UG/L, B. 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. THERE IS EVIDENCE THE PATIENT SUFFERED AN MI. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 714258-00Q. REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: Chest Pain

  MAUDE report 9283904 ↗
• MalfunctionOct 29, 2019False Positive Result; False Positive Result

  NA.

  Patient problems: Fall

  MAUDE report 9250889 ↗
• MalfunctionOct 17, 2019False Positive Result; False Positive Result

  ON (B)(6) 2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT TROPONIN RESULT ON A (B)(6) YEAR OLD MALE PATIENT WITH DIZZINESS. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. (B)(6). 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 PATIENT'S CLINICAL PICTURE THERE IS NO EVIDENCE THE PATIENT SUFFERED AN MI. THERE HAVE BEEN MULTIPLE REQUESTS FOR INFORMATION BUT TO NO AVAIL. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: (B)(4). REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: Dizziness; HIV, Human Immunodeficiency Virus; High Blood Pressure/ Hypertension; Pulmonary Embolism

  MAUDE report 9202865 ↗
• MalfunctionOct 9, 2019False Negative Result; False Negative Result

  ON (B)(6) 2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT TROPONIN RESULT ON A (B)(6) YEAR OLD MALE PATIENT WITH ABNORMAL LEVELS OF OTHER SERUM ENZYMES AND ADMITTED AS A RESULT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). 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 PATIENT'S CLINICAL PICTURE THERE IS NO EVIDENCE THE PATIENT SUFFERED AN MI. THERE HAVE BEEN MULTIPLE REQUESTS FOR INFORMATION BUT TO NO AVAIL. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 714258-00Q. REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: Heart Failure

  MAUDE report 9171504 ↗
• MalfunctionOct 9, 2019False Positive Result; False Positive Result

  ON (B)(6) 2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT TROPONIN RESULT ON A (B)(6) YEAR OLD FEMALE PATIENT WITH GENERAL WEAKNESS. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, DATE: 09/27/2019, TESTED: 23:40, RESULT: 0.27. I-STAT, 09/28/2019, 06:29, 0.00. I-STAT, 09/28/2019, 06:42, 0.03. 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 PATIENT'S CLINICAL PICTURE THERE IS NO EVIDENCE THE PATIENT SUFFERED AN MI. THERE HAVE BEEN MULTIPLE REQUESTS FOR INFORMATION BUT TO NO AVAIL. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 714258-00Q. REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: Weakness

  MAUDE report 9171503 ↗
• MalfunctionSep 24, 2019False Negative Result; False Negative Result

  ON (B)(6) 2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT TROPONIN RESULT ON A (B)(6) YEAR OLD FEMALE PATIENT WITH RAPID PULSE. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. PATIENT #1: (B)(6). 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 PATIENT'S CLINICAL PICTURE THERE IS NO EVIDENCE THE PATIENT SUFFERED AN MI. THERE HAVE BEEN MULTIPLE REQUESTS FOR INFORMATION BUT TO NO AVAIL. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 714258-00Q REPORTABLE RANGE: 0.00 - 50.00 REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS) REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS)

  Patient problems: Irregular Pulse

  MAUDE report 9112478 ↗
• MalfunctionSep 6, 2019False Positive Result; False Positive Result

  ON (B)(6) 2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT TROPONIN RESULT ON A (B)(6) YEAR OLD MALE PATIENT WITH CHEST PAIN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. (B)(6). 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 CUSTOMER STATES THE PATIENT WAS ADMINISTERED HEPARIN BASED ON THE I-STAT RESULT. THE PATIENT RECEIVED AND EKG THAT WAS NORMAL. THE PATIENT WAS ADMITTED IN THE ER AND WAS TRANSFERRED TO ANOTHER FACILITY WHERE HE REMAINED HOSPITALIZED. THE FINAL DIAGNOSIS FROM THE OTHER FACILITY IS UNKNOWN. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 714258-00Q. REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: Chest Pain

  MAUDE report 8969783 ↗
• MalfunctionAug 28, 2019False Negative Result; False Negative Result

  ON 08/15/2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT TROPONIN RESULTS ON A (B)(6) MALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: DATE; COLLECTED; TESTED: RESULT: POSITIVE CUT-OFF: VALUE: I-STAT, (B)(6) 2019, 09:51, 09:51, 0.01 NG/ML, 0.08; DIMENSION EXL, (B)(6) 2019, 09:40, 09:45, 0.196 NG/ML, 0.056. 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. PER I-STAT SYSTEM MANUAL: ART: 714258-00Q REPORTABLE RANGE: 0.00 - 50.00 REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS), REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: No Information

  MAUDE report 8939153 ↗
• MalfunctionAug 28, 2019False Positive Result; False Positive Result

  NA.

  Patient problems: No Information

  MAUDE report 8939150 ↗
• MalfunctionAug 28, 2019False Positive Result; False Positive Result

  ON (B)(6) 2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT TROPONIN RESULTS ON A (B)(6) YEAR OLD MALE PATIENT WITH PAIN IN LEFT ARM. THIS INCIDENT WAS RECEIVED AS PART OF THE ABBOTT POINT OF CARE ACTIVE MONITORING PROGRAM Q3 2019. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). 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. PER I-STAT SYSTEM MANUAL: ART: 714258-00Q. REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: Arthritis; Hyperglycemia; Pain

  MAUDE report 8939149 ↗
• MalfunctionAug 28, 2019False Positive Result; False Positive Result

  ON (B)(6) 2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT TROPONIN RESULTS ON A PATIENT. THIS INCIDENT WAS RECEIVED AS PART OF THE ABBOTT POINT OF CARE ACTIVE MONITORING PROGRAM Q3 2019. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. (B)(6). COLLECTION AND TEST TIME WERE NOT PROVIDED. 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. PER I-STAT SYSTEM MANUAL: ART: 714258-00Q. REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: No Information

  MAUDE report 8939148 ↗
• MalfunctionAug 28, 2019False Negative Result; False Negative Result

  ON (B)(6) 2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT TROPONIN RESULTS ON A (B)(6) YEAR OLD MALE. THIS INCIDENT WAS RECEIVED AS PART OF THE ABBOTT POINT OF CARE ACTIVE MONITORING PROGRAM Q3 2019. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, DATE: 03/12/2019, COLLECTED: 11:59, TESTED: 11:59, RESULT: 0.00 NG/ML, SAMPLE TYPE: WB. LAB, 03/12/2019, 11:59, 12:09, 1.7 NG/ML, NI. 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. PER I-STAT SYSTEM MANUAL: ART: 714258-00Q. REPORTABLE RANGE: 0.00 - 50.00. REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS). REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

  Patient problems: No Information

  MAUDE report 8939147 ↗