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

Model Number FHC-102

Device Problem Display Difficult to Read (1181)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2019

Event Type  malfunction  

Manufacturer Narrative

At the time of the event, there was no indication of a reportable malfunction based on information provided and assessed by alere (b)(4).Alere (b)(4) updated reporting decisions and conducted a retrospective review of complaints against the updated reporting decisions.This mdr is a retrospective filing that was identified during this retrospective review activity associated with an observation from an fda inspection conducted in january 2019 at alere (b)(4) (reference eir (b)(4)).The awareness date is based on updated reporting decisions and completion of the retrospective review activity.There is no new or increased trend based on this retrospective review activity.Investigation results: customer's observation was not replicated in-house with retention devices.Retention devices were tested with 25 miu/ml cutoff hcg urine control and 3 high level of hcg urine controls (205.2 iu/ml, 208.6 iu/ml and 216.8 iu/ml), all results were positive at read time and met qc specification.Mfg batch record review did not uncover any abnormalities.Root cause could not be determined without patient specimen in-house analysis and insufficiency information provided.

Event Description

It was reported that the hcg test had a readability issues with faint test lines which could be missed by staff.There was no report of patient harm.Troubleshooting with the customer did not indicate any technique, sample interference, or other factors contributing to the positive result.

• Brand Name: SURESTEP HCG PREGNANCY DEVICE 40 DET
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 9114278
• MDR Text Key: 191751627
• Report Number: 2027969-2019-00167
• 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,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: FHC-102
• Device Lot Number: HCG4120169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 09/24/2019
• 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: N
• Patient Sequence Number: 1