MAUDE Adverse Event Report: ALERE SAN DIEGO FISHER - SURE-VUE HCG SERUM/URINE; HCG PREGNANCY TEST

Model Number	FHC-202
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results pending completion of the investigation.
Event or Problem Description
The customer reported that a patient with abdominal pain arrived at the hospital.An hcg test was performed with a false positive result on a urine/serum cassette using a serum sample.A urine sample was tested on the same urine/serum cassette with a negative result.Confirmatory testing result with patient's plasma was 8.0miu/ml.No treatment was delayed or medication provided based on the results.
Additional Manufacturer Narrative
Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical urine samples.The results were read at 5 minutes and all devices yielded the expected negative results.No false positive results were observed during in-house testing.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Manufacturing batch record review did not uncover any relevant non-conformances and found that the lot met quality control specifications.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.Review of the information provided did not identify any evidence of misuse.The customer was unsure of the volume used on the test, but the technician couldn't retest sample because of insufficient sample.There were no other indications that the user deviated from the package insert.The minimum detect level for this product is 5miu/ml.The hcg concentration of the patient sample from the reported complaint was 8.0 miu/ml, which is above the minimum detect level.Therefore, positive results may be observed at this concentration.

• Brand Name: FISHER - SURE-VUE HCG SERUM/URINE
• Common Device Name: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 9474051
• Report Number: 2027969-2019-00609
• Device Sequence Number: 2649249
• Product Code: JHI
• UDI-Device Identifier: 00613647000540
• UDI-Public: (01)00613647000540(17)210331(10)HCG9040020
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K993065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: FHC-202
• Device Catalogue Number: 23900529
• Device Lot Number: HCG9040020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR