MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CONSULT HCG URINE CASSETTE 5001 25T; HCG PREGNANCY TEST

Model Number FHC-A102

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

At the time of the event, there was no indication of a reportable malfunction based on information provided and assessed by alere (b)(4).Alere (b)(4) updated reporting decisions and conducted a retrospective review of complaints against the updated reporting decisions.This mdr is a retrospective filing that was identified during this retrospective review activity associated with an observation from an fda inspection conducted in january 2019 at alere (b)(4) (reference eir (b)(4)).The awareness date is based on updated reporting decisions and completion of the retrospective review activity.There is no new or increased trend based on this retrospective review activity.Investigation results: the customer's observation was not replicated in-house with retention and return products.Retention devices were tested with low hcg concentration samples (4miu/ml) and in-house clinically negative urine samples.Return devices were tested with in-house clinically negative urine samples.All hcg results for both return and retain devices were negative at read time and met qc specifications.No false positive results were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities.The root cause could not be determined based on the information provided.

Event Description

It was reported that on (b)(6) 2017, the post-partum patient presented for an iud insertion.The patient's urine was tested on the consult hcg urine cassette x2 and received a positive result x2.Serum testing was performed and yielded a result of 1miu/ml.No further information was provided.

• Brand Name: CONSULT HCG URINE CASSETTE 5001 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: 9226850
• MDR Text Key: 189208302
• Report Number: 2027969-2019-00320
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: FHC-A102
• Device Lot Number: HCG6080014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2019
• 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: N
• Patient Sequence Number: 1
• Patient Age: 17 YR