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 Code Available (3191)

Event Date 06/28/2017

Event Type  Injury  

Manufacturer Narrative

Investigation pending.

Event Description

The customer reported the following events occurring on one patient: on (b)(6) 2017, the patient went to facility for iud removal.The iud had been inserted 45 days earlier at the facility.A urine sample was collected mid-day and a henry schein hcg urine cassette produced a negative hcg result.An ultrasound was subsequently performed and showed gestation of 8 weeks 6 days.Within an hour of the original test run, the urine sample was repeated using a second henry schein hcg urine cassette and produced a positive hcg result.The iud was removed on (b)(6) 2017.Date of last menstrual period= (b)(6) 2017.No additional information provided by the customer.

Manufacturer Narrative

Investigation conclusion: the customer's results were not replicated in-house with returned and retention products of the reported lot.Returned and retention products were tested with three high level hcg clinical urine samples.All devices produced expected positive results at the read time.The product met qc release specifications.False negative results were not observed during the investigation.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: 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: 6745321
• MDR Text Key: 81092916
• Report Number: 2027969-2017-00124
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 10304040024109
• UDI-Public: (01)10304040024109(17)181031(10)HCG6110030
• 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: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-102
• Device Catalogue Number: 9004073
• Device Lot Number: HCG6110030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 25 YR