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

Model Number	92210
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/12/2017
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: the customer's observation was not replicated in-house with retention and return products.Retention and return devices were tested with in-house clinical hcg negative urine samples.All hcg results were negative at read time and met qc specifications.No false positive results were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities.The root cause could not be determined based on the information provided.
Event or Problem Description
On (b)(6) 2017 a patient presented to the emergency department with possibly abdominal pain.(reporter was uncertain) at 6pm a rapid hgc was ordered which displayed a positive result.The patient had a history of tubal ligation, emphatic she was not pregnant.A serum quantitative hcg test was ordered and returned as with a negative result.No treatment or medication was delayed as a result of the rapid test.Lmp was not available.On (b)(6) 2019, the reporter knew of the event, the patient sample was discarded the day before but retrieved, retested with a negative result.Because the customer could not confirm if the collection cup obtained on (b)(6) 2017 was that of the same patient tested on (b)(6) 2017, the customer was not concerned with the possible conflicting results, but was concerned with the fp result between the rapid and the serum quant.

• Brand Name: ALERE HCG CASSETTE
• Common Device Name: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 9114382
• Report Number: 2027969-2019-00439
• Device Sequence Number: 2430693
• Product Code: JHI
• UDI-Device Identifier: 10815845020130
• UDI-Public: (01)10815845020130(17)190630(10)HCG7070005
• 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: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• 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: 06/30/2019
• Device Model Number: 92210
• Device Lot Number: HCG7070005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR