MAUDE Adverse Event Report: SURESTEP HCG PREGNANCY DEVICE; 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 of 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.Root cause could not be determined due to insufficiency 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.This issue will be subject to tracking and trending.

Event Description

Customer reported potential false negative urine hcg results on two patients with the surestep hcg pregnancy device.The test was repeated on both patients with negative results.No other confirmation method was performed.No patient information was provided.The customer reported that the product was stored properly; the user was experienced and testing was performed less than 5 minutes after sample was provided.

• Brand Name: SURESTEP HCG PREGNANCY DEVICE
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5458621
• MDR Text Key: 39006871
• Report Number: 2027969-2016-00115
• 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,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: 4502519002
• Device Lot Number: HCG5070204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2016
• 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