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

Model Number FHC-A202-OBC513

Device Problem False Negative Result (1225)

Patient Problem Test Result (2695)

Event Type  Injury  

Manufacturer Narrative

Investigation is pending.

Event Description

Customer reported that the sure-vue hcg test was negative on an unspecified date.An unspecified procedure was performed and then a serum sample was tested which was positive.Though requested, no additional information has been received to date.

• Brand Name: FISHER-SURE-VUE HCG-STAT SRM/URINE
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5624211
• MDR Text Key: 44166743
• Report Number: 2027969-2016-00286
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-A202-OBC513
• Device Lot Number: HCG5050212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Other