MAUDE Adverse Event Report: ALERE SAN DIEGO ALERE HCG CASSETTE (20MIU/ML); HCG PREGNANCY TEST

Model Number	92210
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Information (3190)
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 for the reported lot number.Retention devices were tested with clinical hcg-negative urine.Results were read at 3 minutes and all devices produced expected negative results.No false positives were observed.Manufacturing batch record review did not uncover any abnormalities.A root cause for the reported issue could not be determined from the available information.
Event or Problem Description
It was reported that false positive occurred when using the hcg cassette, serum hcg quant was negative for pregnancy.Additional testing of the urine sample may have indicated an interference.Customer unable to provide further information.Although requested, no further information has been received.

• Brand Name: ALERE HCG CASSETTE (20MIU/ML)
• Common Device Name: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 9121646
• Report Number: 2027969-2019-00456
• Device Sequence Number: 19416325
• Product Code: JHI
• UDI-Device Identifier: 10815845020130
• UDI-Public: (01)10815845020130(17)200131(10)HCG8020002
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/24/2019

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: 01/31/2020
• Device Model Number: 92210
• Device Lot Number: HCG8020002
• 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: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1