MAUDE Adverse Event Report: ALERE SAN DIEGO, INC HENRY SCHEIN HCG URINE CASSETTE; PREGNANCY TEST

Model Number FHC-102

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 returned devices were tested with clinical negative urine and low concentration standard (3miu/ml).All devices were read at 3 and 4 minutes and yielded expected negative results.Manufacturing batch records of the final-product, relevant product components, and quality control release data were reviewed.No relevant non-conformances, deviations, or abnormalities were found.All quality control specifications were met.Retention and returned devices performed as expected during in-house testing and could not replicate the reported complaint.This issue will be subject to tracking and trending.This test provides a presumptive diagnosis for pregnancy.A false positive result can be caused by a variety of factors and interfering substances.Please refer to the limitations and interfering substances section of the package insert.For these reasons, a secondary analytical method must be used to obtain a confirmed result.

Event Description

Unspecified date: patient presented to facility for late menses.Menses was late by approximately a month.Patient is in a same-sex relationship.Urine specimen was tested on the henry schein one step+ urine cassette and the result was positive.A serum hcg was performed and the result was negative at <2 miu/ml.Customer states there was no negative outcome to the patient.Troubleshooting occurred with a discussion about possible causes for unexpected results focusing on proper sampling technique, storage conditions and patient specific factors per the package insert (pi)-no deviations were noted.Technical services specialist informed customer per the pi, that this test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

• Brand Name: HENRY SCHEIN HCG URINE CASSETTE
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 9121648
• MDR Text Key: 191255815
• Report Number: 2027969-2019-00502
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 10304040024109
• UDI-Public: (01)10304040024109(17)200430(10)HCG8050122
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: FHC-102
• Device Catalogue Number: 9004073
• Device Lot Number: HCG8050122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 09/26/2019
• 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: Initial
• Patient Sequence Number: 1