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

Model Number FHC-102

Device Problem False Negative Result (1225)

Patient Problem Ectopic Pregnancy (1819)

Event Date 01/11/2017

Event Type  Injury  

Manufacturer Narrative

Investigation pending.

Event Description

The customer reported a false negative surestep hcg pregnancy test result as compared to a positive hcg blood test.The customer also provided a roche immunoassay beta hcg result of 180 miu/ml but was unable to specify if this result corresponded with this patient.The patient was reported as experiencing an ectopic pregnancy.Although requested, no additional information was provided.A two other false negative surestep hcg pregnancy test results were reported for different patients and are addressed in mdr 2027969-2017-00032.

Manufacturer Narrative

Investigation conclusion: the customer's observation was not replicated in-house with retention products.Retention products were tested with 25miu/ml hcg as well as three high hcg urine concentrations (211.5iu/ml, 218.1iu/ml and 217.5iu/ml).All devices for all concentrations showed positive results at read time and met qc specifications.No false negative results were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

• Brand Name: SURESTEP HCG PREGNANCY DEVICE 40 DET
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 6324040
• MDR Text Key: 67182308
• Report Number: 2027969-2017-00018
• 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: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-102
• Device Lot Number: HCG6050115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2017
• Initial Date FDA Received: 02/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/13/2017
• 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
• Patient Outcome(s): Life Threatening