MAUDE Adverse Event Report: ALERE SAN DIEGO, INC CARDINAL HEALTH RAPID TEST HCG COMBO; PREGNANCY TEST

Model Number FHC-A202

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2015

Event Type  malfunction  

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: customer's observation was not replicated in-house with retention devices.Retention (n=29) devices were tested in-house with clinical hcg negative serum samples.All results were negative at the 5 minute read time and met qc specifications.No false positive results were observed.Manufacturing batch record review did not uncover any abnormalities.Root cause could not be determined from the information provided and without patient specimen in-house analysis.

Event Description

(b)(6) 2015: false positive result obtained when testing a serum sample on the cardinal health hcg combo rapid test.Confirmatory beta quantitative test was performed and the result was 14.2 (units not specified).Physician indicated that the patient did have a liver abnormality that they were being treated for and the doctor was not surprised by the presence of hcg.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-no deviations noted.

• Brand Name: CARDINAL HEALTH RAPID TEST HCG COMBO
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 9114281
• MDR Text Key: 190779839
• Report Number: 2027969-2019-00478
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: FHC-A202
• Device Lot Number: HCG4060154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 84 YR