MAUDE Adverse Event Report: ALERE SAN DIEGO, INC SURE-VUE SERUM/URINE HCG; HCG PREGNANCY

Model Number FHC-202-OBC513

Device Problem False Negative Result (1225)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/23/2014

Event Type  malfunction  

Event Description

Caller alleged false negative hcg results.Results as follows: pt presented in the er with vaginal bleeding.A urine hcg test was run with negative results (no line at all).Urine sample was very bloody.Quantitative result= 10,000miu/ml.The tech repeated the sure vue test approximately an hour later, and it was clearly positive.Pt was transferred to a nearby larger hospital with a suspected miscarriage.Last menstrual period: 2 months ago.

Manufacturer Narrative

Investigation pending.

• Brand Name: SURE-VUE SERUM/URINE HCG
• Type of Device: HCG PREGNANCY
• 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: 3826345
• MDR Text Key: 4391654
• Report Number: 2027969-2014-00170
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-202-OBC513
• Device Lot Number: HCG3050109
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2014
• 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 Age: 22 YR