MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CARDINAL HEALTH RAPID TEST HCG CASS. 30T; HCG PREGNANCY TEST

Model Number FHC-102

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: the customer's results were not replicated in-house with retention and returned devices of the reported lot.Retention and returned devices were tested with clinical hcg-negative urine and hcg-positive urine standard (25 miu/ml).All devices tested with clinical hcg-negative urine produced negative results.Additionally, all devices tested with hcg-positive urine standard produced positive results.All of the results met the qc specification.Conflicting results were not observed 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 customer reported the following events occurring on one patient: the patient received a negative result using the cardinal health rapid test hcg cassette prior to surgery.The patient underwent surgery; no information regarding the surgery is available.One week after the surgery, the patient was retested and a positive hcg result was produced.Although requested, no additional information is available from the customer.

Manufacturer Narrative

Corrections: unique identifier (udi) number corrected to (b)(4).

• Brand Name: CARDINAL HEALTH RAPID TEST HCG CASS. 30T
• 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: 6527443
• MDR Text Key: 73870947
• Report Number: 2027969-2017-00077
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20885380020251
• UDI-Public: 20885380020251
• 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: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-102
• Device Lot Number: HCG6090031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/03/2017
• 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): Other