i-STAT 05p58-25Recalls & reported problems
Abbott Point Of Care Inc. · CARTRIDGE, Total B-hCG · Class 2
Quick summary
This Abbott i-STAT Total B-hCG cartridge is a point-of-care test for human chorionic gonadotropin, a pregnancy hormone. Its 105 reports are all malfunction reports, and nearly all describe false positive results, where the test showed a positive result that other tests did not match. There were no deaths and no injuries, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 105
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 10054749001009), received between Jul 10, 2017 and Apr 16, 2024 — classified as 105 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (103 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.
Reports received per month
Most reported problems
Device problems
- False Positive Result103
- False Negative Result2
Patient problems
- Abdominal Pain26
- No Information22
- No Clinical Signs, Symptoms or Conditions14
- Nausea10
- Vomiting9
- Pain6
- Headache5
- No Code Available5
Recent adverse event reports
The 25 most recent of 105 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2024False Positive Result; False Positive Result
MalfunctionApr 2, 2024False Positive Result; False Positive Result
ON 27-MAR-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT B-HCG CARTRIDGES THAT YIELDED A POSITIVE RESULT ON A 13 YEAR OLD FEMALE PATIENT WITH OSTEOGENESIS IMPERFECTA. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE TESTED RESULTS SAMPLE I-STAT (B)(6) 2024 09:26 30.3 1 I-STAT (B)(6) 2024 09:50 23.7 2 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. I-STAT POSITIVE CUT-OFF VALUES: B-HCG < 5.0 IU/L NEGATIVE 5.0 < SS-HCG < 25.0 IU/L INDETERMINATE B-HCG >25.0 IU/L POSITIVE INTENDED USE: THE I-STAT® TOTAL BETA-HUMAN CHORIONIC GONADOTROPIN (B-HCG) TEST IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUANTITATIVE AND QUALITATIVE DETERMINATION OF B-HCG IN VENOUS WHOLE BLOOD OR PLASMA SAMPLES USING THE I-STAT 1 ANALYZER SYSTEMS. THE TEST IS INTENDED TO BE USED AS AN AID IN THE EARLY DETECTION OF PREGNANCY AND IS FOR PRESCRIPTION USE ONLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19023292 ↗MalfunctionMar 19, 2024False Positive Result; False Positive Result
MalfunctionFeb 14, 2024False Positive Result; False Positive Result
ON 19-JAN-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT B-HCG CARTRIDGES THAT YIELDED A POSITIVE RESULT ON A 39 YEAR OLD FEMALE PATIENT WITH ABDOMINAL PAIN, NAUSEA, DIARRHEA. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD; DATE; COLLECTED; TESTED & RESULT. I-STAT, (B)(6) 2022, 2:03PM, 2:14PM & 52.6 IU/ML. ROCHE, (B)(6) 2022, NI, NI & <5.0 IU/ML. 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. I-STAT POSITIVE CUT-OFF VALUES: B-HCG < 5.0 IU/L NEGATIVE. 5.0 < SS-HCG < 25.0 IU/L INDETERMINATE. B-HCG >25.0 IU/L POSITIVE. INTENDED USE: THE I-STAT® TOTAL BETA-HUMAN CHORIONIC GONADOTROPIN (B-HCG) TEST IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUANTITATIVE AND QUALITATIVE DETERMINATION OF B-HCG IN VENOUS WHOLE BLOOD OR PLASMA SAMPLES USING THE I-STAT 1 ANALYZER SYSTEMS. THE TEST IS INTENDED TO BE USED AS AN AID IN THE EARLY DETECTION OF P
Patient problems: Abdominal Pain; Diarrhea; Nausea
MAUDE report 18702697 ↗MalfunctionFeb 14, 2024False Positive Result; False Positive Result
NA.
Patient problems: Abdominal Pain; Decreased Appetite; Dysuria; Nausea; Vomiting
MAUDE report 18702696 ↗MalfunctionFeb 14, 2024False Positive Result; False Positive Result
MalfunctionFeb 14, 2024False Positive Result; False Positive Result
NA.
Patient problems: Dysphasia; Hallucination; Memory Loss/Impairment; Nausea; Numbness
MAUDE report 18702677 ↗MalfunctionFeb 14, 2024False Positive Result; False Positive Result
ON 19-JAN-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT B-HCG CARTRIDGES THAT YIELDED A POSITIVE RESULT ON A 47 YEAR OLD FEMALE PATIENT WITH ALCOHOL INTOXICATION. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD; DATE; COLLECTED; TESTED; RESULT (IU/ML). I-STAT 1, (B)(6) 2023, 8:59PM, 9:14PM & 49.7 (POSITIVE). ROCHE, NI, NI, NI & <5.0 (NEGATIVE). 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. I-STAT POSITIVE CUT-OFF VALUES: B-HCG < 5.0 IU/L, NEGATIVE. 5.0 < SS-HCG < 25.0 IU/L, INDETERMINATE. B-HCG >25.0 IU/L, POSITIVE. INTENDED USE: THE I-STAT® TOTAL BETA-HUMAN CHORIONIC GONADOTROPIN (B-HCG) TEST IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUANTITATIVE AND QUALITATIVE DETERMINATION OF B-HCG IN VENOUS WHOLE BLOOD OR PLASMA SAMPLES USING THE I-STAT 1 ANALYZER SYSTEMS. THE TEST IS INTENDED TO BE USED AS AN AID IN THE EARLY DETECTION OF
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18702673 ↗MalfunctionFeb 14, 2024False Positive Result; False Positive Result
ON 19-JAN-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT B-HCG CARTRIDGES THAT YIELDED A POSITIVE RESULT ON A 51 YEAR OLD FEMALE PATIENT WITH FLANK PAIN AND A COUGH. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD; DATE; COLLECTED; TESTED & RESULT (IU/ML). I-STAT, (B)(6) 2023, 02:53AM, 03:05AM & 31.3. I-STAT, (B)(6) 2023, 03:24AM, 03:36AM & 36.3. ROCHE, (B)(6) 2023, NI, NI & <5.0. 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. I-STAT POSITIVE CUT-OFF VALUES: B-HCG < 5.0 IU/L; NEGATIVE. 5.0 < SS-HCG < 25.0 IU/L; INDETERMINATE. B-HCG >25.0 IU/L; POSITIVE . INTENDED USE: THE I-STAT® TOTAL BETA-HUMAN CHORIONIC GONADOTROPIN (B-HCG) TEST IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUANTITATIVE AND QUALITATIVE DETERMINATION OF B-HCG IN VENOUS WHOLE BLOOD OR PLASMA SAMPLES USING THE I-STAT 1 ANALYZER SYSTEMS. THE TEST IS INTENDED TO BE USED
Patient problems: Cough; Pain
MAUDE report 18702668 ↗MalfunctionFeb 14, 2024False Positive Result; False Positive Result
MalfunctionFeb 14, 2024False Positive Result; False Positive Result
ON 19-JAN-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT B-HCG CARTRIDGES THAT YIELDED A POSITIVE RESULT ON A 43 YEAR OLD FEMALE PATIENT WITH VOMITING, EMESIS, DIARRHEA, AND ABDOMINAL PAIN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD; DATE; COLLECTED; TESTED; RESULT (IU/ML) I-STAT, (B)(6) 2023, 10:59AM, 11:10AM & 35.2. ROCHE, (B)(6) 2023, NI, NI & <5.0. 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. I-STAT POSITIVE CUT-OFF VALUES: B-HCG < 5.0 IU/L, NEGATIVE. 5.0 < SS-HCG < 25.0 IU/L, INDETERMINATE. B-HCG >25.0 IU/L, POSITIVE. INTENDED USE: THE I-STAT® TOTAL BETA-HUMAN CHORIONIC GONADOTROPIN (B-HCG) TEST IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUANTITATIVE AND QUALITATIVE DETERMINATION OF B-HCG IN VENOUS WHOLE BLOOD OR PLASMA SAMPLES USING THE I-STAT 1 ANALYZER SYSTEMS. THE TEST IS INTENDED TO BE USED AS AN AID IN THE EARLY D
Patient problems: Abdominal Pain; Diarrhea; Nausea; Vomiting
MAUDE report 18702665 ↗MalfunctionFeb 14, 2024False Positive Result; False Positive Result
MalfunctionFeb 14, 2024False Positive Result; False Positive Result
MalfunctionFeb 14, 2024False Positive Result; False Positive Result
MalfunctionFeb 14, 2024False Positive Result; False Positive Result
ON 19-JAN-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT B-HCG CARTRIDGES THAT YIELDED A POSITIVE RESULT ON A 23 YEAR OLD FEMALE PATIENT WITH LEG PAIN, AND NUMBNESS RIGHT TOE. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED RESULT (IU/ML) I-STAT ON (B)(6) 2023 01:04 PM 01:15 PM 33.8 ROCHE ON (B)(6 2023 NI NI <5.0 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. I-STAT POSITIVE CUT-OFF VALUES: B-HCG < 5.0 IU/L NEGATIVE 5.0 < SS-HCG < 25.0 IU/L INDETERMINATE B-HCG >25.0 IU/L POSITIVE INTENDED USE: THE I-STAT® TOTAL BETA-HUMAN CHORIONIC GONADOTROPIN (B-HCG) TEST IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUANTITATIVE AND QUALITATIVE DETERMINATION OF B-HCG IN VENOUS WHOLE BLOOD OR PLASMA SAMPLES USING THE I-STAT 1 ANALYZER SYSTEMS. THE TEST IS INTENDED TO BE USED AS AN AID IN THE EARLY DETECTION OF PREGNANCY AND IS
Patient problems: Limb Pain; Numbness
MAUDE report 18702661 ↗MalfunctionJan 16, 2024False Positive Result; False Positive Result
MalfunctionJan 10, 2024False Positive Result; False Positive Result
ON 02-JAN-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT B-HCG CARTRIDGES THAT YIELDED A POSITIVE RESULT ON A 45 YEAR OLD FEMALE PATIENT WITH ABDOMINAL PAIN, PELVIC PAIN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED RESULT (UNITS) SAMPLE I-STAT (B)(6) 2023 8:32 AM 8:32 AM 37.6 IU/L VENOUS #1 I-STAT (B)(6) 2023 8:32 AM 9:02 AM 73.0 IU/L VENOUS #1 VITROS (B)(6) 2023 8:28 AM 9:03 AM <2 MIU/ML VENOUS #2 I-STAT POSITIVE CUT-OFF VALUES: B-HCG = 5.0 IU/L NEGATIVE 5.0 < SS-HCG < 25.0 IU/L INDETERMINATE B-HCG = 25.0 IU/L POSITIVE 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: Abdominal Pain
MAUDE report 18482974 ↗MalfunctionJan 10, 2024False Positive Result; False Positive Result
ON 02-JAN-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT B-HCG CARTRIDGES THAT YIELDED A POSITIVE RESULT ON A 43 YEAR OLD FEMALE PATIENT WITH MALIGNANT NEOPLASM. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED RESULT (UNITS) SAMPLE I-STAT (B)(6) 23 8:47 AM 8:47 AM 77.5 IU/L VENOUS #1 VITROS (B)(6) 23 8:55 AM 9:29 AM <2 MIU/ML VENOUS #2 I-STAT POSITIVE CUT-OFF VALUES: B-HCG = 5.0 IU/L NEGATIVE 5.0 < SS-HCG < 25.0 IU/L INDETERMINATE B-HCG = 25.0 IU/L POSITIVE 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: Non-malignant Neoplasm
MAUDE report 18482973 ↗MalfunctionJan 10, 2024False Positive Result; False Positive Result
ON 02-JAN-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT B-HCG CARTRIDGES THAT YIELDED A POSITIVE RESULT ON A 60 YEAR OLD FEMALE PATIENT WITH POST-MENOPAUSAL BLEEDING. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED RESULT SAMPLE I-STAT (B)(6) 2023 09:50 09:50 102.4 IU/L VENOUS #1 VITROS (B)(6) 2023 13:33 14:02 <2 MIU/ML VENOUS #2 I-STAT POSITIVE CUT-OFF VALUES: B-HCG = 5.0 IU/L NEGATIVE 5.0 < SS-HCG < 25.0 IU/L INDETERMINATE B-HCG = 25.0 IU/L POSITIVE 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: Intermenstrual Bleeding
MAUDE report 18482972 ↗MalfunctionNov 14, 2023False Positive Result; False Positive Result
ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT B-HCG CARTRIDGES THAT YIELDED A POSITIVE RESULTS ON A 34 YEAR OLD FEMALE 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 (UNITS) SAMPLE I-STAT, (B)(6) 2023, 16:14, 16:14, >2000 IU/L, VENOUS #1. NI, (B)(6) 2023, 16:14, NI, <2.4 MIU/ML , VENOUS #1. I-STAT POSITIVE CUT-OFF VALUES: B-HCG = 5.0 IU/L , NEGATIVE. 5.0 < SS-HCG < 25.0 IU/L, INDETERMINATE. B-HCG = 25.0 IU/L, POSITIVE. 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 18131478 ↗MalfunctionNov 14, 2023False Positive Result; False Positive Result
ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT B-HCG CARTRIDGES THAT YIELDED A POSITIVE RESULTS ON A 22 YEAR OLD FEMALE PATIENT WITH HEADACHES. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE TESTED RESULT SAMPLE I-STAT ON(B)(6) 2023 0819 1367 IU/L A ROCHE ON (B)(6) 2023 0814 <1 IU/L B I-STAT POSITIVE CUT-OFF VALUES: B-HCG = 5.0 IU/L NEGATIVE 5.0 < SS-HCG < 25.0 IU/L INDETERMINATE B-HCG = 25.0 IU/L POSITIVE 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: Headache
MAUDE report 18131476 ↗MalfunctionNov 14, 2023False Positive Result; False Positive Result
ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT B-HCG CARTRIDGES THAT YIELDED A POSITIVE RESULT OF >2000 IU/L ON A 22 YEAR OLD FEMALE PATIENT WITH GENERALIZED ABDOMINAL PAIN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. METHOD, DATE, COLLECTED, TESTED, RESULT, SAMPLE; I-STAT, (B)(6) 2023, 0149, 0149, >2000 IU/L, VENOUS #1; NI, (B)(6) 2023, 0149, NI, <2.4 MIU/ML, VENOUS #1. I-STAT POSITIVE CUT-OFF VALUES: B-HCG = 5.0 IU/L, NEGATIVE. 5.0 < SS-HCG < 25.0 IU/L, INDETERMINATE. B-HCG = 25.0 IU/L POSITIVE 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: Abdominal Pain
MAUDE report 18131473 ↗MalfunctionNov 14, 2023False Positive Result; False Positive Result
ON 07-NOV-2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT B-HCG CARTRIDGES THAT YIELDED A POSITIVE RESULTS ON A 25 YEAR OLD FEMALE PATIENT WITH HEADACHES. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD, DATE, COLLECTED, TESTED, RESULT, SAMPLE; I-STAT, (B)(6) 2023, 6:22 PM, 6:22 PM, 96.6 IU/L, VENOUS #1; NI, (B)(6) 2023, 6:22 PM, NI, <2.4 MIU/ML, VENOUS #1; I-STAT, (B)(6) 2023, 8:19 PM, 8:19 PM, 162 IU/L, VENOUS #2; I-STAT POSITIVE CUT-OFF VALUES: B-HCG = 5.0 IU/L, NEGATIVE. 5.0 < SS-HCG < 25.0 IU/L, INDETERMINATE. B-HCG = 25.0 IU/L, POSITIVE. 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: Headache
MAUDE report 18131472 ↗MalfunctionNov 14, 2023False Positive Result; False Positive Result
ON (B)(6)2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT B-HCG CARTRIDGES THAT YIELDED A POSITIVE RESULTS ON A 12 YEAR OLD FEMALE PATIENT WITH SICKLE CELL. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE TESTED RESULT SAMPLE I-STAT, (B)(6)2023, 1214, 373 IU/L, A. ROCHE, (B)(6)2023, 1218, <1 IU/L , B. I-STAT POSITIVE CUT-OFF VALUES: B-HCG = 5.0 IU/L , NEGATIVE. 5.0 < SS-HCG < 25.0 IU/L , INDETERMINATE. B-HCG = 25.0 IU/L , POSITIVE . 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 18131470 ↗MalfunctionNov 8, 2023False Positive Result; False Positive Result
ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT B-HCG CARTRIDGES THAT YIELDED A POSITIVE RESULT ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED RESULT SAMPLE: I-STAT (B)(6) 2023 3:49 PM 166.2 WHOLE BLOOD. LAB COBAS (B)(6) 2023 4:08 PM <0.6 SERUM. LAB COBAS (B)(6) 2023 5:43PM <0.6 SERUM. I-STAT (B)(6) 2023 6:01 PM <5.0 WHOLE BLOOD . I-STAT POSITIVE CUT-OFF VALUES: B-HCG = 5.0 IU/L NEGATIVE. 5.0 < SS-HCG < 25.0 IU/L INDETERMINATE. B-HCG = 25.0 IU/L POSITIVE . 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 18091752 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.