MAUDE Adverse Event Report: FISHER-SURE-VUE HCG STAT SRM/URINE (50T); HCG PREGNANCY TEST

Model Number FHC-A202-OBC513

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Cyst(s) (1800); Rupture (2208); Weight Changes (2607)

Event Date 07/07/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion.Investigation pending.

Event Description

Report received of false negative urine hcg on fisher-sure-vue hcg stat srm/urine (50t) on (b)(6) 2016 a (b)(6) female with "abdominal pain, obesity, right ruptured ovarian cyst, vitamin d deficiency" was tested multiple times.Patient's lmp (b)(6) 2016.No injuries or invasive procedures were performed based on the false negative results.No treatment was withheld based on false negative results.Patient confirmed to be pregnant.Confirmatory test result = serum quant (positive 1310 miu/ml).

• Brand Name: FISHER-SURE-VUE HCG STAT SRM/URINE (50T)
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5848399
• MDR Text Key: 52288781
• Report Number: 2027969-2016-00555
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-A202-OBC513
• Device Lot Number: HCG5120235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 17 YR