MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HCG COMBO DEVICE SP BRAND RAPID TEST; HCG PREGNANCY TEST

Model Number FHC-A202-OBW515

Device Problem False Negative Result (1225)

Patient Problems Abdominal Pain (1685); Ectopic Pregnancy (1819)

Event Date 08/03/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: customer's observation was not replicated in-house with retention devices.Retention devices were tested with 20 miu/ml hcg urine control and 3 high level of hcg urine controls (205.2 iu/ml, 208.6 iu/ml and 216.8 iu/ml), all results were hcg positive at read time.No false negatives were obtained.Manufacturing batch record review did not uncover any abnormalities.Root cause could not be determined without patient specimen in-house analysis.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Event Description

Customer (er) alleging false negative urine hcg for one patient.Ectopic pregnancy confirmed by surgery.Patient admitted for abdominal pain.The urine was collected at admission ((b)(6) 2015), time unknown, and tested immediately.Diagnosis: ectopic pregnancy, length unknown.Outcome: ectopic pregnancy removed by surgery.Patient discharged.Serum quant: not performed.Ultrasound: unknown no additional information provided.

• Brand Name: HCG COMBO DEVICE SP BRAND RAPID TEST
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer (Section G): ABON BIOPHARM (HANGOU) CO. LTD.; #198 12th street east; hangzhou economic & technologi; hangzhou, zhejiang zhejiang 31001 8; CH 310018
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5062183
• MDR Text Key: 25838430
• Report Number: 2027969-2015-00653
• 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: Health Professional
• Type of Report: Initial
• Report Date: 08/12/2015

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-A202-OBW515
• Device Lot Number: HCG5030074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2015
• Initial Date FDA Received: 09/08/2015
• 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