MAUDE Adverse Event Report: ALERE SAN DIEGO CONSULT HCG URIN/SRM COMBO 5002; HCG PREGNANCY TEST

Model Number	FHC-A202
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of the event, there was no indication of a reportable malfunction based on information provided and assessed by alere (b)(4).Alere (b)(4) updated reporting decisions and conducted a retrospective review of complaints against the updated reporting decisions.This mdr is a retrospective filing that was identified during this retrospective review activity associated with an observation from an fda inspection conducted in january 2019 at alere (b)(4) (reference eir (b)(4)).The awareness date is based on updated reporting decisions and completion of the retrospective review activity.There is no new or increased trend based on this retrospective review activity.Investigation results: an investigation was performed on retention products fro the reported lot number.Retention products were tested with negative clinical urine.Results were read at 3-4 minutes and all devices correctly yielded negative results.Manufacturing batch record review did not uncover any abnormalities.A root cause for the reported issue could not be determined based on the information provided.
Event or Problem Description
It was reported that on (b)(6) 2018 a patient presented with symptoms of pregnancy at the health center.The hcg combo cassette was administered with a confirmed false positive result, serum hcg same day was <1miu/ml.The patient received two negative results using an at home hcg test.No procedures performed based on the questionable test result & any adverse clinical outcomes.Troubleshooting occurred reviewing the possible contributions to the false-positive result including storage/handling and technique.

• Brand Name: CONSULT HCG URIN/SRM COMBO 5002
• Common Device Name: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 9130552
• Report Number: 2027969-2019-00531
• Device Sequence Number: 2528657
• Product Code: JHI
• UDI-Device Identifier: 20612479202768
• UDI-Public: (01)20612479202768(17)190228(10)HCG7030080
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K062361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2019

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: 02/28/2019
• Device Model Number: FHC-A202
• Device Lot Number: HCG7030080
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 09/27/2019
• 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