MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY GLUCOSE

Catalog Number	03L82-21
Medical Device Problem Codes	Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed multiple falsely depressed glucose results while using clinical chemistry glucose reagents.The following data was provided for the same patient: sid: (b)(6) (serum) initial 47 mg/dl, repeat 47 mg/dl.Glucometer reading 15 minutes earlier was higher, 158 mg/dl.Previous results for the patient using the clinical chemistry glucose method ranged from 44 to 47 mg/dl.The customer stated the patient takes vitamin d, a multivitamin, fenlasaxine (150 mg, 2 tablets per day) and n-acetyl-l-cysteine (600 mg, 4 tablets per day).No change to medication was reported due to the falsely depressed glucose results.No impact to patient management was reported.
Additional Manufacturer Narrative
Evaluation of the customer issue included complaint text review, a search for similar complaints, device history review, labeling review, and field data review.No adverse trend was identified for the customer issue.Device history review did not identify any issues that may have caused the customer issue.Labeling was reviewed and found to be adequate.Abbott link world wide data was used to evaluate product historical performance field data.The evaluation indicated that the patient median result for the complaint lot was comparable to other lots in the field with test results generated between may 28, 2017 and may 26, 2018.No unusual reagent lot performance was identified.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.

• Brand Name: CLINICAL CHEMISTRY GLUCOSE
• Common Device Name: GLUCOSE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7478071
• Report Number: 1628664-2018-00170
• Device Sequence Number: 1510401
• Product Code: CFR
• UDI-Device Identifier: 00380740006006
• UDI-Public: 00380740006006
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 03L82-21
• Device Lot Number: 51494UQ07
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1