MAUDE Adverse Event Report: ALERE SAN DIEGO, INC ALERE HCG CASSETTE; PREGNANCY TEST

Model Number	92217
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2018
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: retention devices for the reported lot number were tested with clinical hcg negative urine.All test devices produced expected negative results at the read time.No false positive results were observed during testing.Manufacturing batch record review did not uncover any abnormalities and qc data met specifications.The reported complaint for false positive results was not replicated as retention devices performed as expected.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.Customer to monitor.Devices not returned.
Event or Problem Description
(b)(6) 2018: patient presented to the facility for a missed period.Patient urine specimen was tested on the alere hcg cassette and a positive result was obtained.Positive result was questioned as the patient has a tubal ligation.Customer states quantitative beta serum hcg tests were performed, however, no further information was able to be provided.Unspecified dates: customer observed an additional three false positive results on three separate patients when testing on the alere hcg cassette kit.Customer states quantitative beta serum hcg tests were performed, however, no further information was able to be provided.The customer was not able to provide further patient details.Tss confirmed no delay in treatment or adverse outcomes due to false positive results on the alere hcg cassette for any of the patients.The customer stated that it is their procedure to perform confirmatory testing when a positive pregnancy result is interpreted on the alere hcg cassette.Troubleshooting occurred with a discussion about possible causes for unexpected results focusing on proper sampling technique, storage conditions and patient specific factors per the package insert (pi)-no deviations noted.Technical services specialist informed customer per the pi: 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.

• Brand Name: ALERE HCG CASSETTE
• Common Device Name: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 9131295
• Report Number: 2027969-2019-00537
• Device Sequence Number: 19445441
• Product Code: JHI
• UDI-Device Identifier: 10815845020109
• UDI-Public: (01)10815845020109(17)200229(10)HCG8030053
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K993317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• 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: 02/29/2020
• Device Model Number: 92217
• Device Lot Number: HCG8030053
• 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
• Outcome Attributed to Adverse Event: Required Intervention