MAUDE Adverse Event Report: 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 No Consequences Or Impact To Patient (2199)

Event Date 11/11/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: customer's observation was not reproduced in-house with retain devices.Retain devices were tested with hcg 25 miu/ml cutoff urine controls and 3 different levels of high hcg urine control (201.8 iu/ml, 203.4 iu/ml and 205.2 iu/ml); all results met qc specification and produced positive results.No false negatives were obtained.Manufacturing batch record review did not uncover any abnormalities.Root cause could not be determined due to insufficient information provided by the customer and 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

Report received of a false negative urine hcg test.Event occurred in (b)(6).Patient's lmp 4 months ago.Reporter claims patient confirmed to be (b)(6) pregnant, however, did not report any confirmation testing results.No reported patient ae.No additional details provided.

• Brand Name: HCG ONE STEP PREGNANCY TEST STRIP (URINE/SERUM)
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5285890
• MDR Text Key: 33172216
• Report Number: 2027969-2015-00998
• 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: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2015

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)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: No
• 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