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 04/14/2018

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: there was no increase in complaints or trend observed.This is the only complaint on lot hcg8010022.Retained product lot hcg7110128 was tested with clinically negative serum samples, as well as low level hcg samples (2 miu/ml serum).The testing results indicated that all devices yielded correct negative results at the appropriate read times.The retained product testing indicated the product performed as expected and met qc specifications.The customer's observation was not replicated.Manufacturing batch record review did not uncover any abnormalities.A root cause could not be determined based on the information provided.

Event Description

A customer reported that there is an increase in false positives on older patients at the facility.On (b)(6) 2018, a (b)(6) year old woman had a serum sample tested on (b)(6) 2018 and the result was positive.Serum quant test was performed on the same day, (result not provided, but was low); customer stated the quant test was negative.The customer is not alleging any delay in treatment and/or patient harm related to use on the hcg combo cassette.No additional information available from customer.This is the first 2027969-2019-00486 of two files.The second file is 2027969-2019-00486.

• 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: 9121630
• MDR Text Key: 191249437
• Report Number: 2027969-2019-00486
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20885380020268
• UDI-Public: (01)20885380020268(17)191231(10)CG8010022
• 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: 09/25/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: FHC-A202
• Device Catalogue Number: B1077-23
• Device Lot Number: HCG8010022
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 09/26/2019
• Was Device Evaluated by Manufacturer?: No
• 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: 50 YR