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

Model Number FHC-102

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: the customer's observation was not replicated in-house with retention and return products.Retention and return devices were tested with in-house clinical hcg negative urine samples.All hcg results were negative at read time and met qc specifications.No false positive results were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities.From the literature, a number of conditions other than pregnancy can cause elevated levels of hcg.E.G.Menopause, trophoblastic disease and hcg injections.Hcg may also remain elevated for several weeks after delivery, abortion and natural termination.Based on the information provided by the customer some of the patients were postpartum.In this case, positive results may be observed due to low hcg levels unrelated to pregnancy.Because the specimen associated with the complaint was not returned for investigation, a root cause could not be determined based on the information provided.

Event Description

It was reported that a site location has higher than expected rates of false positives.Although requested, no other information has been received.Troubleshooting occurred with proper storage, handling of the cassettes, proper testing technique and emphasized the importance of the read time for the test.Tss advised the read time for this test is 3-4 minutes and results should not be interpreted after that read time.Tss advised a first morning urine specimen is preferred since it generally contains the highest concentration of hcg; however, urine specimens collected at any time of the day may be used.

• Brand Name: CARDINAL HEALTH RAPID TEST HCG CASS. 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: 9114372
• MDR Text Key: 192706400
• Report Number: 2027969-2019-00417
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20885380020251
• UDI-Public: (01)20885380020251(17)181130(10)HCG6120200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993317
• 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

• 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-102
• Device Catalogue Number: B1077-22
• Device Lot Number: HCG6120200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Is the Reporter a Health Professional?: Yes
• 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