MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY GLUCOSE

Catalog Number 03L82-21

Device Problem High Test Results (2457)

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

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

A review for any complaints against glucose reagent lot 51839uq09 was performed, and no other complaints or trends were identified.Return testing was not completed as returns were not available.The field service engineer inspected the instrument and identified a rusty wire in the incubator, and water pressure to the probe wash cups and mixer was low.The o-rings and diaphram pump parts were replaced proactively.After the repairs were performed, assay performance was checked and was acceptable.The instrument result log during the time frame was reviewed to confirm the customer's report.The samples with the glucose values attributed to the complaint were not located.In addition, the sample ids reported by the customer were not located in the log.The actual printouts from the customer were requested, but were not available.A review of labeling concluded sufficient information is provided to detect, troubleshoot and resolve results related problems, should they occur.Erratic results and/or poor precision is addressed in the operations manual with the most likely causes to be either sample preparation or instrument hardware.Manufacturing documentation for glucose, list number 3l82 was reviewed and no contributing factors to the complaint could be identified.Based on this investigation no product deficiency was identified for glucose reagent, lot 51839uq09.This issue was previously reported under mdr number (1415939-2018-00072) associated with the incorrect manufacturing site.

Event Description

The customer reported a falsely elevated glucose result on one patient.The results provided were: initial = 360mg/dl / repeat with a new sample was normal (approximately 90mg/dl).There was no reported impact to patient management.

• Brand Name: CLINICAL CHEMISTRY GLUCOSE
• Type of Device: GLUCOSE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 8020374
• MDR Text Key: 126544594
• Report Number: 1628664-2018-01981
• Device Sequence Number: 1
• Product Code: CFR
• UDI-Device Identifier: 00380740006006
• UDI-Public: 00380740006006
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 03L82-21
• Device Lot Number: 51839UQ09
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1