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 Type  malfunction  

Manufacturer Narrative

Investigation pending.

Event Description

The distributor reported the events on behalf of the customer.The customer reported receiving false negative hcg results using the henry schein hcg urine cassette on seven different patients.The pregnancies were confirmed by ultrasound.Although requested, no additional information was provided.

Manufacturer Narrative

Additional information: in an update provided by the distributor, the customer stated the test line on the henry schein hcg urine cassette was dark and solid.Additional clarification was requested due to the conflicting information.A correction was provided by the customer that a positive hcg result was received using the henry schein hcg urine cassette and a confirmatory blood test was negative.This event is no longer considered a reportable malfunction as the event is not considered likely to cause or contribute to a death or serious injury.Correction: (patient information) have been intentionally left blank as this is not considered a reportable event.(adverse event or product problem) have been intentionally left blank as this is not considered a reportable event.(suspect medical device) have been intentionally left blank as this is not considered a reportable event.(initial reporter) have been intentionally left blank as this is not considered a reportable event.(all manufacturers) have been intentionally left blank as this is not considered a reportable event.(type of reportable event): this event is no longer considered a reportable malfunction as the event is not considered likely to cause or contribute to a death or serious injury.However, this is a mandatory field that requires an entry.Therefore, malfunction has only been selected to represent the type of reportable event for the initial report.(device manufacturers) have been intentionally left blank as this is not considered a reportable event.

Event Description

Initial report information: the distributor reported the events on behalf of the customer.The customer reported receiving false negative hcg results using the henry schein hcg urine cassette on seven different patients.The pregnancies were confirmed by ultrasound.Although requested, no additional information was provided.Updated information: in an update provided by the distributor, the customer stated the test line on the henry schein hcg urine cassette was dark and solid.Additional clarification was requested due to the conflicting information.A correction was provided by the customer that a positive hcg result was received using the henry schein hcg urine cassette and a confirmatory blood test was negative.This event is no longer considered a reportable malfunction as the event is not considered likely to cause or contribute to a death or serious injury.

• 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
• MDR Report Key: 7130949
• MDR Text Key: 95665863
• Report Number: 2027969-2017-00188
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 10304040024109
• UDI-Public: (01)10304040024109(17)190228(10)HCG7020197
• Combination Product (y/n): N
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

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: 02/28/2019
• Device Model Number: FHC-102
• Device Catalogue Number: 9004073
• Device Lot Number: HCG7020197
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 12/21/2017
• Supplement Dates FDA Received: 01/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1