MAUDE Adverse Event Report: ALERE SAN DIEGO ALERE HCG CASSETTE; HCG PREGNANCY KIT

Model Number	FHC-A102
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer: (b)(4).Device available for evaluation: yes.Manufacturer site: (b)(4).Device evaluated by manufacturer: yes.Investigation conclusion: the case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.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.Batch record review found no relevant non-conformances; the lot met all final release specifications.An investigation was performed on retention and returned products for the reported lot number.Retention devices were tested with clinical negative urine samples and results were read at 3 minutes.All test devices produced expected negative results at the read time.Returned devices were tested with low hcg patient urine sample (2.6 miu/ml).Results were read at 3 minutes and all devices tested produced negative results.Unable to replicate the reported issue during-house testing.Per the package insert, this test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.
Additional Manufacturer Narrative
Results pending completion of the investigation.
Event or Problem Description
It was reported that a (b)(6) old patient visited the clinic and an hcg cassette test was administered with a urine sample.A faint positive result occurred.Retest was administered two times with a negative result.Confirmatory testing will not be conducted.The patient was not provided/withheld treatment nor were there changes in medication due to the hcg results.No adverse patient outcome.

• Brand Name: ALERE HCG CASSETTE
• Common Device Name: HCG PREGNANCY KIT
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 9143348
• Report Number: 2027969-2019-00556
• Device Sequence Number: 19585153
• Product Code: JHI
• UDI-Device Identifier: 10815845020130
• UDI-Public: (01)10815845020130(17)210228(10)HCG9030081
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K062361
• 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): 12/11/2019

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: 02/28/2021
• Device Model Number: FHC-A102
• Device Lot Number: HCG9030081
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR