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

Catalog Number FHC-A202-OBW515

Device Problem False Negative Result (1225)

Patient Problems Abdominal Pain (1685); Dehydration (1807); Pyrosis/Heartburn (1883); Electrolyte Imbalance (2196)

Event Date 03/27/2015

Event Type  malfunction  

Event Description

Customer reported a potential (b)(6) urine hcg result when testing with hcg combo device sp brand rapid test.A female patient presented in the ed on (b)(6) 2015 at 8am with heartburn, abdominal pain, dehydration and potassium imbalance.When tested with hcg combo device sp brand rapid test at this time, a negative result was observed.Later the same day at 3pm, the patient had heartburn and gerd.When patient was tested again using the same product, a positive result was observed.A serum quantitative test was performed with a result of 108040miu/ml.On (b)(6) 2015 the same patient had gastroenteritis.

Manufacturer Narrative

Customer's observation was not replicated in-house with retention devices.Retention devices were tested with 20 miu/ml cutoff hcg urine control and 205.2 iu/ml hcg urine control, all results were positive at read time.No false negatives results were obtained.Manufacturing batch record review did not uncover any abnormalities.Root cause could not be determined without patient specimen in-house analysis and with insufficient information from customer.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.This issue will be subject to tracking and trending.

• 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 rd.; san diego CA 92121
• Manufacturer (Section G): ABON BIOPHARM (HANGZHOU) CO., LTD; #198 12th street east; hangzhou, zhejiang zhejiang 3100 18; CH 310018
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4743924
• MDR Text Key: 19995780
• Report Number: 2027969-2015-00320
• 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: 04/21/2015

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 Expiration Date: 12/31/2015
• Device Catalogue Number: FHC-A202-OBW515
• Device Lot Number: HCG4010140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2015
• Initial Date FDA Received: 05/01/2015
• 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