MAUDE Adverse Event Report: ABBOTT LABORATORIES CLINICAL CHEMISTRY GLUCOSE

Catalog Number	03L82-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2018
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.No additional patient information was obtained from the customer.
Event or Problem 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.
Additional Manufacturer Narrative
Correction to suspect medical device; 4.Lot # from unknown to lot 51839uq09.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.
Additional Manufacturer Narrative
After further evaluation, the manufacturing site in section d and section g, 1.2 of this report was found to be incorrect.The new mdr number (1628664-2018-01981) has been submitted with the correct manufacturing location and all further information will be documented under that mdr number.
Additional Manufacturer Narrative
After further evaluation, the manufacturing site of this report was found to be incorrect.The new mdr number (1628664-2018-01981) has been submitted with the correct manufacturing location and all further information will be documented under that mdr number.

• Brand Name: CLINICAL CHEMISTRY GLUCOSE
• Common Device Name: GLUCOSE
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 7402703
• Report Number: 1415939-2018-00072
• Device Sequence Number: 785256
• Product Code: CFR
• UDI-Device Identifier: 00380740006006
• UDI-Public: 00380740006006
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2018

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: 09/30/2018
• Device Catalogue Number: 03L82-21
• Device Lot Number: 51839UQ09
• Initial Date Received by Manufacturer: 03/14/2018
• Supplement Date Received by Manufacturer: 05/07/2018; 10/30/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 05/07/2018; 10/30/2018
• 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: ARCHITECT C8000 SYSTEM, LIST # 01G06-11; ARCHITECT C8000 SYSTEM, LIST # 01G06-11; ARCHITECT C8000 SYSTEM, LIST # 01G06-11; SERIAL # (B)(4); SERIAL # (B)(4); SERIAL # (B)(4)