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

Model Number FHC-202F-ONW01

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2014

Event Type  malfunction  

Event Description

Customer reported potential false negative urine hcg results on one patient's urine sample with hcg one step pregnancy test device (urine/serum) when compared to serum quantitative test.(b)(6) 2014: test 1 - urine hcg test - negative; serum bhcg result = 33iu/l.(b)(6) 2014: test 2 - urine hcg repeated = faint line, (b)(6) 2014: test 3 - urine hcg repeated = positive.Result; serum result = 33.60iu/l on one lab analyzer; serum test repeated result = 34.48 iu/l; beta hcg on urine sample = 34.24iu/l.(b)(6) 2014: urine hcg repeated with negative result; serum beta hcg test result = 72iu/l.No further patient information available.The distributor rep also asked if the patient was confirmed pregnant but the customer did not provide additional information.

Manufacturer Narrative

Customer's observation was not replicated in-house with retention devices.Retention devices were tested with cutoff (25 miu/ml) hcg urine controls.All results were positive at read time.No false negatives were observed.Manufacturing batch record review did not uncover any abnormalities.Customer reported serum bhcg was 72 iu/l.Hcg concentration in urine is usually lower than in serum.Patient's hcg levels in urine may have been below cutoff.Unable to determine root cause 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.This issue will be subject to tracking and trending.

• Brand Name: HCG ONE STEP PREGNANCY TEST DEVICE (URINE/SERU)
• Type of Device: HCG PREGNANCY 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: 3942091
• MDR Text Key: 19924842
• Report Number: 2027969-2014-00180
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K993065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: FHC-202F-ONW01
• Device Lot Number: HCG3050056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2014
• 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
• Patient Age: 23 YR