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

Model Number 4502529003

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's observation was not replicated in-house with retention products.Retention products were tested with low and high positive levels of hcg urine control.All results showed hcg positive results at read time and met qc specifications.No false negative results 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

Event occurred in (b)(6).Report received of false negative hcg results received on surestrip hcg pregnancy strips 50 det.Reportedly, a female patient, (b)(6), presented with sudden onset right sided abdominal pain that lasted 45 minutes.Clinically was found to have right iliac fossa tenderness.Urine pregnancy test performed and results were found to be negative.Patient referred for further investigation and pregnancy test repeated.Positive results were received on second pregnancy test.The second test was tested with alere cassette -no confirmation of product code and lot no.The customer also indicated that it is not possible to give the batch number and product code as this was done in a different department.Reportedly, blood tests were performed for the patient but the range is not known.No other confirmatory data provided.There was no delay or impact to patient's treatment, as a result of this negative hcg result.The patient was using the following medication at the time of test: lymecycline; cerazette.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: 6086304
• MDR Text Key: 59426507
• Report Number: 2027969-2016-00674
• 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: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4502529003
• Device Lot Number: HCG6050114
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: CERAZETTE.; LYMECYCLINE
• Patient Age: 24 YR