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

Model Number FHC-101

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's observation was not replicated in-house with retention products.Retention products were tested with qc cutoff hcg concentrations and high positive hcg urine standards.All devices showed positive results at read time and met qc specifications.No false negative results were obtained during in-house testing.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.

Event Description

The following information was provided by the distributor regarding an incident occurring on one patient: on (b)(6) 2017, a non-first morning urine sample was collected from the patient and produced a negative result using the henry schein hcg dipstick test.The patient received a positive hcg result the same day via a blood test.Although requested, no additional information was provided.

Manufacturer Narrative

Investigation conclusion: the customer's observation was not replicated in-house with retention and return products.Retention and return products were tested with qc cutoff hcg concentrations and high positive hcg urine standards.All devices showed positive results at read time and met qc specifications.No false negative results were obtained during in-house testing.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 DIPSTICK 25T (URINE)
• 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: 6778564
• MDR Text Key: 82631625
• Report Number: 2027969-2017-00127
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 10304040024093
• UDI-Public: (01)10304040024093(17)181031(10)HCG6110029
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-101
• Device Catalogue Number: 9004072
• Device Lot Number: HCG6110029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2017
• 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 Age: 33 YR