MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HCG ONE STEP PREGNANCY TEST STRIP (URINE/SERUM); HCG PREGNANCY TEST

Model Number FHC-211B/4-ONN01(25T/B)

Device Problem False Negative Result (1225)

Patient Problem Pregnancy (3193)

Event Date 07/01/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: customer's observation was not replicated in-house with retention devices.Retention devices were tested with 25 miu/ml hcg urine/serum cutoff control, 3 high level of hcg urine controls (205.2 iu/ml, 208.6 iu/ml and 216.8 iu/ml, 500 iu/ml), and 6 pregnant in 7 weeks - 23 weeks clinical urine samples, all results were 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

Notification received from distributor.Event occurred in (b)(6).Customer complaint false negative hcg results.Reportedly, patient was pregnant but no confirmatory method provided.Although requested, no additional information provided.No adverse events reported.

• Brand Name: HCG ONE STEP PREGNANCY TEST STRIP (URINE/SERUM)
• 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: 4954794
• MDR Text Key: 24651024
• Report Number: 2027969-2015-00551
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K980736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Report Date: 07/01/2015

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-211B/4-ONN01(25T/B)
• Device Lot Number: M04KUS03-86
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/30/2015
• 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