MAUDE Adverse Event Report: SURESTEP HCG PREGNANCY DEVICE 40 DET; HCG PREGNANCY TEST

Model Number 4502519002

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2016

Event Type  malfunction  

Manufacturer Narrative

Customer's observation was not replicated in-house with retention devices.Retention devices were tested with 25 miu/ml hcg cutoff urine control and 3 high level hcg urine controls (201.4 iu/ml, 204.2 iu/ml and 212.2 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.The root cause could not be determined based on the information provided by the 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 from the (b)(6) of potential false negative hcg for one patient.When testing with surestep hcg pregnancy test.The test was repeated with a negative result.It is unknown whether the same sample was used.No confirmatory testing was performed.It was reported that relevant patient medications or medical history was taken.Although requested, no further details have been provided.There was no reported adverse patient sequela.

• Brand Name: SURESTEP HCG PREGNANCY DEVICE 40 DET
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5660966
• MDR Text Key: 45368873
• Report Number: 2027969-2016-00322
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/26/2016

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 Model Number: 4502519002
• Device Lot Number: HCG5070204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2016
• Initial Date FDA Received: 05/17/2016
• 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