MAUDE Adverse Event Report: ALERE SAN DIEGO FISHER-SURE-VUE HCG STAT SRM/URINE; HCG PREGNANCY TEST

Model Number FHC-A202

Device Problem False Positive Result (1227)

Patient Problem No Information (3190)

Event Date 04/17/2018

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: retention and return devices were tested with in-house clinical hcg negative urine samples.All hcg results were negative at read time and met qc specifications.No false positive results were obtained during in-house testing.The product performed as expected.Manufacturing batch record review did not uncover any abnormalities.Root cause could not be determined from the information provided.

Event Description

It was reported that on (b)(6) 2018, a patient arrived at the medical center with upper quadrant rib pain on the left side; the patient described the pain as being sharp in nature.It was intermittent pain that periodically flares up.There was no bowel or bladder issues.The doctor tested patient's urine on the rapid test first and it was positive.From this positive result, the doctor considered her to be pregnant.Serum quant result on (b)(6) 2018 0.0 miu/ml.The doctor then sent the patient to the obstetrics department for an ultrasound to identify if there was an intrauterine pregnancy.Based off the ultrasound, they could not confirm if there was an identifiable intrauterine pregnancy.The ct scan was then conducted on 4/19, and had all normal findings, patient was not pregnant.The ob department proceeded to send for a serum quant test again.On (b)(6) 18 the same serum sample from 4/17 was tested again on the beckman coulter=0.2 miu/ml.

• Brand Name: FISHER-SURE-VUE HCG STAT SRM/URINE
• 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: 9121633
• MDR Text Key: 191254090
• Report Number: 2027969-2019-00485
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00613647000533
• UDI-Public: (01)00613647000533(17)190731(10)HCG7080105
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: FHC-A202
• Device Catalogue Number: 23900531
• Device Lot Number: HCG7080105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 18 YR
• Patient Weight: 50