MAUDE Adverse Event Report: ALERE SAN DIEGO, INC HCG COMBO DEVCIE SP BRAND RAPID TEST; HCG PREGANCY TEST

Model Number FHX-A202-OBW515

Device Problem False Negative Result (1225)

Patient Problem Pregnancy (3193)

Event Date 03/04/2014

Event Type  malfunction  

Event Description

Customer reported potential false negative urine hcg test with hcg combo device sp brand rapid test vs.Serum quantitative test.On (b)(6) 2014, a (b)(6) year old female pt presented to the ed and had a negative urine hcg test with hcg combo device sp brand rapid test.Four hours later her blood was drawn an a serum quantitative test result was 1,000miu/ml.At 8pm or 9pm that night surgery was performed to remove a molar pregnancy.Serum sample was collected on (b)(6) 2014 with a quantitative result of 840, 000miu/ml.The original serum sample was re-run on the lab analyzer after being diluted since it was over the instrument's linearity and the result was 3,062,184miu/ml.The pt has post-op transfusion reaction (uticarial).Urine sample was recollected and gave a positive result.A urine sample was collected on (b)(6) 2014 and gave a positive result.On (b)(6) 2014, a serum sample was collected and the quantitative result was 163,000miu/ml.Ultrasound had been performed pre-op (no date provided, no details).

Manufacturer Narrative

Investigation pending.

• Brand Name: HCG COMBO DEVCIE SP BRAND RAPID TEST
• Type of Device: HCG PREGANCY TEST
• 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: 3813420
• MDR Text Key: 4365190
• Report Number: 2027969-2014-00279
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2014

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: FHX-A202-OBW515
• Device Lot Number: HCG3010237
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2014
• Initial Date FDA Received: 03/27/2014
• 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: 24 YR