MAUDE Adverse Event Report: SURESTRIP HCG PREGNANCY STRIPS 50 DET; HCG PREGNANCY TEST

Model Number FHC-101

Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion customer's observation was not replicated in-house with retention product.Retention products were tested with 25 miu/ml hcg cutoff urine control and 3 high level of hcg urine controls (205.3 iu/ml, 210.7 iu/ml and 216.8 iu/ml), all results were hcg positive at read time and met qc specification.No false negatives were obtained.Manufacturing batch record review did not uncover any abnormalities.Root cause could not be determined based on the information provided by customer.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 customer receiving two false negative urine hcg results for one patient on surestrip hcg pregnancy strips 50 det.Event occurred in (b)(6).The first hcg pregnancy test was performed on the (b)(6) 2016 and the repeat pregnancy test was performed on (b)(6) 2016.The patient was showing symptoms of pregnancy so the physician sent the patient for a blood test and when tested in the lab patient was confirmed to be pregnant.The test was run by the lab using serum hcg.Serum bhcg = 59.08.Patient was taking metformin.No reported adverse patient sequela.

• Brand Name: SURESTRIP HCG PREGNANCY STRIPS 50 DET
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5867079
• MDR Text Key: 51888896
• Report Number: 2027969-2016-00565
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K993203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2016

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: 09/30/2017
• Device Model Number: FHC-101
• Device Lot Number: HCG5100056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2016
• Initial Date FDA Received: 08/10/2016
• 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