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

Catalog Number	07P55-30
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely decreased glucose results generated from an alinity c processing module for a female patient who was in the icu.The customer provided the following data: sample id (b)(6) was originally run on (b)(6)2023 at 0630 for a complete metabolic panel.Later that day at approximately 2130 there was a request to add a basic metabolic panel.The results were questioned on (b)(6) so the sample was repeated on the same analyzer (sn:(b)(6)) and also repeated on another alinity c processing module (sn:(b)(6)) glucose results: initial glucose result on (b)(6)was 53, repeated later that day the result was 224, repeated on the same analyzer on (b)(6)was 220, repeated on another analyzer was 209.There was no reported impact to patient management.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from alinity c glucose reagent kit, list number:07p55-30, and manufacturing site: abbott gmbh, max-planck-ring 2, wiesbaden, 65205 germany to alinity c processing module, ln 03r67-01, abbott laboratories, 1915 hurd drive, irving, tx, 75038.Mdr number 3016438761-2023-00485 has been submitted and all further information will be documented under that mdr number.H3 other text : after further evaluation, the suspect medical device was changed from alinity c glucose reagent kit, list number:07p55-30 to alinity c processing module, ln 03r67-01.Mdr number 3016438761-2023-00485 has been submitted and all further information will be documented under that mdr number.
Event or Problem Description
The customer observed falsely decreased glucose results generated from an alinity c processing module for a female patient who was in the icu.The customer provided the following data: sample id (b)(6)was originally run on (b)(6)2023 at 0630 for a complete metabolic panel.Later that day at approximately 2130 there was a request to add a basic metabolic panel.The results were questioned on 20 july, so the sample was repeated on the same analyzer (sn: (b)(6)) and also repeated on another alinity c processing module (sn: (b)(6)) glucose results: initial glucose result on 18 july was 53, repeated later that day the result was 224, repeated on the same analyzer on 20 july was 220, repeated on another analyzer was 209.There was no reported impact to patient management.

• Brand Name: ALINITY C GLUCOSE REAGENT KIT
• Common Device Name: HEXOKINASE, GLUCOSE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17437675
• Report Number: 3002809144-2023-00337
• Device Sequence Number: 20546559
• Product Code: CFR
• UDI-Device Identifier: 00380740135447
• UDI-Public: 00380740135447
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K170316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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 Catalogue Number: 07P55-30
• Device Lot Number: 63170UQ11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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: ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
• Patient Sex: Female