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

Model Number FHC-A202

Device Problem False Positive Result (1227)

Patient Problem No Information (3190)

Event Date 04/30/2017

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: the customer's observation was not replicated in-house with retention and return products of the reported lot.Retention and return devices were tested with in-house clinical hcg negative urine and serum samples and low concentration urine and serum standards.All hcg results showed expected negative results at read time.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 Description

It was reported that a patient presented to the emergency room on (b)(6) 2019 with unknown status and was administered an hcg urine rapid test that resulted in a false positive with a weak line in the test region.A serum sample was collected with another weak false positive line on the hcg rapid test.Serum quant performed with 3 miu/ml and not pregnant as a result.Although requested, no further information was received.This file, 2027969-2019-00534, is one of two files.The second file is 2027969-2019-00375.Troubleshooting occurred with a review of the proper technique, sample handling, and storage per the pi, limitations section of the pi and no deviations noted.

• Brand Name: CARDINAL HEALTH RAPID TEST HCG COMBO
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 9131775
• MDR Text Key: 190008380
• Report Number: 2027969-2019-00534
• 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,user faci
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: FHC-A202
• Device Lot Number: HCG6120199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Date Manufacturer Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR