MAUDE Adverse Event Report: HENRY SCHEIN HCG DIPSTICK 25T (URINE); HCG PREGNANCY TEST

Model Number FHC-101-KHS25

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Customer's observation was not replicated in-house with retention devices.Retention devices were tested with 25 miu/ml hcg cutoff urine control and 3 high level of hcg urine controls (205.3 iu/ml, 210.7 iu/ml and 216.8 iu/ml), all results were hcg positive at read time and met qc specification.No false negatives were obtained.Manufacturing batch record review did not uncover any abnormalities.Root cause could not be determined based on the information provided by customer.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Event Description

Customer reported potential false negative urine hcg results on three patients when testing with henry schein hcg dipstick 25t vs.Blood tests that gave positive results.No dates were provided when actual testing was performed.The caller did mention that she had performed one of the tests and did observe a negative result.They questioned the result because the patient had done 6 home pregnancy tests: 2 were positive and 4 negative.This patient did have a positive blood test.No further details were provided.Customer did confirm that there were no adverse events and patients were not treated for anything based on the negative results.

• Brand Name: HENRY SCHEIN HCG DIPSTICK 25T (URINE)
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5750126
• MDR Text Key: 48192833
• Report Number: 2027969-2016-00472
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: FHC-101-KHS25
• Device Lot Number: HCG5080105
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2016
• 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