MAUDE Adverse Event Report: ABBOTT GERMANY CLINICAL CHEMISTRY GLUCOSE

Catalog Number	07P55-20
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2019
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.Complete sid: (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a falsely decreased glucose result generated on the alinity c analyzer on one (b)(6) female patient.Results provided: sid (b)(6), (b)(6) 2019 = 28.557 / 367.804 / another alinity = 365.545 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
Return testing was not completed as returns were not available.A review of ticket trending did not identify any complaints that were similar for falsely depressed glucose patient results.The trend review by the product list number found no trends related to this issue.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no product deficiency was identified.

• Brand Name: CLINICAL CHEMISTRY GLUCOSE
• Common Device Name: GLUCOSE
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 8910060
• Report Number: 3002809144-2019-00514
• Device Sequence Number: 1904254
• Product Code: CFR
• UDI-Device Identifier: 00380740135447
• UDI-Public: 00380740135447
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2019

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: 08/31/2019
• Device Catalogue Number: 07P55-20
• Device Lot Number: 53466UQ08
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALINITY C ANALYZER LIST 03R67-01; ALINITY C ANALYZER LIST 03R67-01; SERIAL AC01791; SERIAL AC01791
• Patient Age: 60 YR