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

Model Number FHC-A202

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2019

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: manufacturing batch record review did not uncover any abnormalities.Retain testing was performed on the reported lot number utilizing clinical negative serum and urine samples as well as 2miu/ml hcg serum standards respectively.The testing results indicated that all of the devices yielded the correct and expected negative results with the clinical negative serum as well as the low concentration standard.The product met qc release specification.From the complaint information, the customer reported that patients had concentration of 4-7miu/ml.This is a sensitive product with a cutoff of 10 miu/ml for hcg serum samples.Studies have shown that when this product is tested with 5 miu/ml hcg serum samples, a certain percentage of faint positive results may be observed.This cannot be ruled out as a potential root cause for the unexpected results.

Event Description

It was reported that a patient's result on the hcg test was a false positive.The patient was not pregnant; used sample for validating cardinal health hcg combo rapid test.Serum quant was 4 miu/ml using centaur xp.No treatment was given on discrepant result and there was no patient impact/outcome.Troubleshooting with a discussion of the issue and potential factors per the pi, reviewed storage, sampling, and technique.

• Brand Name: CARDINAL HEALTH HCG COMBO RAPID TEST
• 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: 9114351
• MDR Text Key: 191280577
• Report Number: 2027969-2019-00403
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20885380020268
• UDI-Public: (01)20885380020268(17)181130(10)HCG6120108
• 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: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• 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 Catalogue Number: B1077-23
• Device Lot Number: HCG6120108
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2019
• 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