MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. MCKESSON HCG DIPSTICK; HCG PREGNANCY TEST

Model Number FHC-111-OBN01

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2014

Event Type  malfunction  

Event Description

Customer alleged potential false negative urine hcg results using the mckesson hcg dipstick.Patient is currently (b)(6) weeks pregnant.The following information was reported: (b)(6) 2014: last menstrual period (exact date not provided); (b)(6) 2014: negative urine test - lot number not provided; (b)(6) 2014: positive urine test - lot number hcg4010247.Additionally, the sample was collected @ approximately 2pm, read time @ three (3) minutes.

Manufacturer Narrative

Investigation/conclusion: the customer did not provide a lot number or return any products for investigation.Unable to perform further investigation without additional information.Since the product associated with the complaint was not returned, manufacturing record review could not be performed and further investigation was not possible.

Manufacturer Narrative

(b)(4).

• Brand Name: MCKESSON HCG DIPSTICK
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4295307
• MDR Text Key: 5190389
• Report Number: 2027969-2014-01062
• Device Sequence Number: 1
• Product Code: JHI
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FHC-111-OBN01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 18 YR