MAUDE Adverse Event Report: ALERE SAN DIEGO CARDINAL HEALTH RAPID TEST HCG COMBO 30T; HCG PREGNANCY TEST

Model Number FHC-A202

Device Problem False Positive Result (1227)

Patient Problem No Information (3190)

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: retention and returned products were tested with clinical negative urine, clinical negative serum, low hcg concentration serum (2miu/ml) and low hcg concentration urine (4miu/ml).All devices yielded expected negative results on all sample types at their respective read times.Manufacturing batch record review did not uncover any abnormalities.A root cause could not be determined based on the information provided.This test provides a presumptive diagnosis for pregnancy.A false positive result can be caused by a variety of factors and interfering substances.Please refer to the limitations and interfering substances section of the package insert.For these reasons, a secondary analytical method must be used to obtain a confirmed result.

Event Description

It was reported that false positive results have occurred when administering the hcg combo test.The customer believes this has occurred at least 10 times; the known occurrences were stated as follows: 5-6 times on 4/11, 2 times last week.The events have occurred on various patients ranging in all ages (the caller believes the cutoff age for a required hcg is below 13 and above 65).The patients are ordered an hcg test when arriving in the er or a scheduled surgery.The caller is not aware of any specific treatment which was provided or delayed due to the rapid result, however, it was mentioned that if an x-ray were needed, it would be delayed if the rapid result was interpreted as positive - she is unsure if x-rays were needed in any of these events.Serum quantification performed by an ortho 5600 at the facility with a cutoff of 6 miu/ml hcg.A value is reported from the analyzer even when the quant is below the cutoff.Some reported with 0 miu/ml hcg, other values obtained were 2.5 miu/ml, 5.5 miu/ml, and 7 miu/ml (which was reported as a negative because it was so close to the cutoff).This file 2027969-2019-00470 is the 3rd of 4 files.The first 2027969-2019-00468, 2nd 2027969-2019-00469, 4th 2027969-2019-00471.

• Brand Name: CARDINAL HEALTH RAPID TEST HCG COMBO 30T
• 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: 9121602
• MDR Text Key: 191251531
• Report Number: 2027969-2019-00470
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20885380020268
• UDI-Public: (01)20885380020268(17)191031(10)HCG7110051
• 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: 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: FHC-A202
• Device Catalogue Number: B1077-23
• Device Lot Number: HCG7110051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 09/26/2019
• 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