MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C GLUCOSE REAGENT KIT; HEXOKINASE, GLUCOSE

Model Number 07P5520

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided by the customer due to privacy issues.

Event Description

The customer reported falsely elevated glucose results on one patient generated on the alinity c processing module.The results provided were: initial = 13mmol/l (234.23mg/dl) / retested = 12mmol/l (216.22mg/dl); the next day, same patient, new draw at (b)(6) = about 5 mmol/l (90.09mg/dl).There was no reported impact to patient management.

Manufacturer Narrative

A review of tickets was performed for reagent lot number 58044uq09.The ticket search determined that there is normal complaint activity for the reagent lot.A review of tracking and trending by list number did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the alinity c glucose reagent ln 7p55-20/lot number 58044uq09 was identified.

• Brand Name: ALINITY C GLUCOSE REAGENT KIT
• Type of Device: HEXOKINASE, GLUCOSE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 12211544
• MDR Text Key: 262950215
• Report Number: 3002809144-2021-00442
• Device Sequence Number: 1
• Product Code: CFR
• UDI-Device Identifier: 00380740135447
• UDI-Public: 00380740135447
• Combination Product (y/n): N
• PMA/PMN Number: K170316
• 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: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 07P5520
• Device Catalogue Number: 07P55-20
• Device Lot Number: 58044UQ09
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, AC03608.; ALNTY C PROCESSING MODU, 03R67-01, AC03608.; ALNTY C PROCESSING MODU, (B)(4)