MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD ALINITY I TSH REAGENT KIT

Model Number 07P4830

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

A physician questioned alinity i tsh results for a (b)(6) year old female patient.The result in (b)(6) 2020 was 4.766 miu/ml.The result in february was 7.870 miu/ml.The samples were not retested.(b)(6) result 4.766 miu/ml.(b)(6) result 7.870 miu/ml.The customer uses a normal range of 0.35 - 4.94 miu/ml.The physician questioned the difference between results in a short time period since the patient had not taken any medication.No additional testing was performed to determine whether either of the results were incorrect.No adverse impact to patient management was reported.

Manufacturer Narrative

No customer returns were available.Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Complaint searches determined that there is normal complaint activity for the likely cause lot.Labeling was reviewed and found to be adequate.Manufacturing documentation was reviewed and no contributing factors to the complaint could be identified.Testing was performed using an in-house retained kit and all specifications were met indicating the lot is preforming acceptably.Based on the available information, no product deficiency was identified.

• Brand Name: ALINITY I TSH REAGENT KIT
• Type of Device: TSH
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 9988873
• MDR Text Key: 225721723
• Report Number: 3005094123-2020-00092
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 00380740131159
• UDI-Public: 00380740131159
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2021
• Device Model Number: 07P4830
• Device Catalogue Number: 07P48-30
• Device Lot Number: 05456UI00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I PROCESSING MODULE; ALINITY I PROCESSING MODULE; LN 03R65-01, SN (B)(6) ; LN 03R65-01, SN (B)(6)
• Patient Age: 47 YR