MAUDE Adverse Event Report: ALERE SAN DIEGO INC MCKESSON HCG CASSETTE (25T)

Model Number FHC-102-OBW12

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2014

Event Type  malfunction  

Event Description

Customer reported an unconfirmed false negative urine hcg result with mckesson hcg cassette (25t).Patient presented at facility for pregnancy test; a positive test result is needed for medicaid eligibility.Test result with the mckesson hcg test was negative.Patient told customer that she had a urine pregnancy test performed 2 days ago (nearby facility) and it was positive.No quantitative serum test was performed; no sample available for testing.Patient is on an antibiotic for uti (uncertain if bactrim).Patient's last menstrual period: (b)(6) 2014.

Manufacturer Narrative

Customer's observation was not replicated in-house with retention devices.Retention devices were tested with hcg 25 miu/ml cutoff urine control and 100 miu/ml hcg urine control, all results were positive at read time.No false negatives were obtained.Manufacturing batch record review did not uncover any abnormalities.Root cause could not be determined without patient specimen in-house analysis.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.This issue will be subject to tracking and trending.

• Brand Name: MCKESSON HCG CASSETTE (25T)
• Manufacturer (Section D): ALERE SAN DIEGO INC; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 3962598
• MDR Text Key: 4626085
• Report Number: 2027969-2014-00612
• Device Sequence Number: 1
• Product Code: JHI
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: FHC-102-OBW12
• Device Lot Number: HCG3060208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2014
• 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