MAUDE Adverse Event Report: CONSULT HCG URINE CASSETTE 5001- 25T; HCG PREGNANCY TEST

Model Number FHC-A102-OBC554

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Ectopic Pregnancy (1819)

Event Type  malfunction  

Manufacturer Narrative

The discrepant results reported were obtained using test strips that expired in february 2014.Product should not be used beyond the stated expiration date, as doing so can result in errors or inaccurate results.Customers are advised not to use product beyond the stated expiration date.Further investigation cannot be pursued because there is no lot number.Trend code analysis is performed in the monthly complaint review.

Event Description

Customer reported a potential false negative urine hcg result with consult hcg urine cassette.An alere account executive, reported that a customer had false negative results on an hcg kit (no lot number provided).One patient had a negative result when a urine hcg test was performed using the consult hcg urine cassette test; the patient had an ectopic pregnancy and was required to have surgery.No dates were available and no further information was provided.Technical service representative made several attempts to contact the customer without success.The customer finally did call back and stated that the hcg cassettes that were used had expired in february 2014 (no lot number was provided).

• Brand Name: CONSULT HCG URINE CASSETTE 5001- 25T
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5251599
• MDR Text Key: 32181523
• Report Number: 2027969-2015-00973
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-A102-OBC554
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1