MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HENRY SCHEIN HCG URINE CASSETTE 25T; HCG PREGNANCY TEST

Model Number FHC-102

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer was unable to provide the lot number of the complaint product.Neither manufacturing record review nor testing on reserve sample from the same lot could not be performed.Further investigation is not possible at this time.

Event Description

The event was reported by the distributor on behalf of the customer.The customer tested herself at facility due to suspected pregnancy.The customer's last menstrual period was (b)(6) 2018.On (b)(6) 2018, the customer suspected pregnancy as she missed her menstrual period.The customer tested herself using a henry schein hcg urine cassette and received a negative hcg result.However, the customer stated that she believed it was too early in the pregnancy for the hcg concentration to be detected by the rapid assay.On (b)(6) 2018, the customer still had not had her menstrual period.A first-morning urine sample was tested using a second henry schein hcg urine cassette and a second negative hcg result was received.Blood work was performed the same day and a beta hcg quantitative result of 677 miu/ml was received.On (b)(6) 2018, the customer performed a third henry schein hcg urine cassette test and received a positive hcg result.The customer later opted to terminate the pregnancy based on the beta hcg quantitative result.Troubleshooting was conducted with the customer.The customer was determined to be reading the henry schein hcg urine cassette results at 5 minutes instead of 3-4 minutes as instructed by the package insert.The customer was advised of the importance of interpreting the test at the designated read time and using a timer.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 25T
• Type of Device: HCG 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: 7856933
• MDR Text Key: 119653931
• Report Number: 2027969-2018-00116
• Device Sequence Number: 1
• Product Code: JHI
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-102
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2018
• 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: Initial
• Patient Sequence Number: 1