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 Date 08/17/2016

Event Type  malfunction  

Manufacturer Narrative

Pending investigation.

Event Description

The distributor reported two false negative hcg results on the same specimen from a patient using the (b)(6) hcg dipstick 25t (urine).The pregnancy was confirmed by a serum quantitative hgc test, which produced a positive result of approximately 500 miu/ml.The patient's last menstrual period was approximately 3 weeks prior to event on (b)(6) 2016.

• Brand Name: HENRY SCHEIN HCG DIPSTICK 25T (URINE)
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5955045
• MDR Text Key: 54893398
• Report Number: 2027969-2016-00623
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2016

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 Model Number: FHC-101-KHS25
• Device Lot Number: HCG5060116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2016
• Initial Date FDA Received: 09/15/2016
• 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