MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CREATININE REAGENT KIT; ALKALINE PICRATE, COLORIMETRY, CREATININE

Model Number 07P9920

Device Problem High Test Results (2457)

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

Event Date 06/01/2022

Event Type  malfunction  

Event Description

The customer observed falsely elevated alinity c creatinine results for one patient.The following data was provided: (b)(6) 2022 sid (b)(6) initial result = 2.88 mg/dl, (b)(6) 2022 sid (b)(6) initial result = 1.94 mg/dl, reference laboratory result = 1.9 mg/dl.No impact to patient management was reported.

Manufacturer Narrative

Completed information for patient identifier: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

This issue was previously reported under initial mdr number 3002809144-2022-00211.Upon further review, mdr number 3002809144-2022-00219 was a duplicate report.All further information will be documented under mdr number 3002809144-2022-00211.H3 other text : this issue was previously reported under initial mdr number 3002809144-2022-00211.Upon further review, mdr number 3002809144-2022-00219 was a duplicate report.All further information will be documented under mdr number 3002809144-2022-00211.

• Brand Name: ALINITY C CREATININE REAGENT KIT
• Type of Device: ALKALINE PICRATE, COLORIMETRY, CREATININE
• 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: 14801368
• MDR Text Key: 297368736
• Report Number: 3002809144-2022-00219
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 00380740135102
• UDI-Public: 00380740135102
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

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
• Device Operator: Health Professional
• Device Model Number: 07P9920
• Device Catalogue Number: 07P99-20
• Device Lot Number: 81084UN21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 06/24/2022
• Supplement Dates Manufacturer Received: 06/27/2022
• Supplement Dates FDA Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1