MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CARBON DIOXIDE REAGENT KIT; ENZYMATIC, CARBON-DIOXIDE

Model Number 07P7220

Device Problem High Test Results (2457)

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

Event Date 10/06/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: (b)(6) (could not accommodate the amount of characters in the field).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed a false elevated alinity c carbon dioxide (co2) result for a (b)(6) year old male patient while using the alinity c processing module.The customer¿s normal range for adults is 22 ¿ 29 mmol/l.The following data was provided: on (b)(6) 2021, sample id (b)(6) = initial result = 36.03 mmol/l, repeat results = 21.28, 20.80 mmol/l.There was no impact to patient management reported.

Manufacturer Narrative

A ticket search by product lot number found normal complaint activity.The trend reviews by product list number identified no trends related to the current complaint issue.Quarterly maintenance was performed, and no other discrepant results have been observed.Returns were not available.File sample analysis was not performed as the issue appears to be specific to the documented patient sample.As part of troubleshooting, the sample was retested and gave lower results.Quality control (qc) results were reported to be within expected ranges indicating the assay is performing as expected.Device history record was reviewed and identified no non-conformances or deviations related to the likely cause and complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for alinity c carbon dioxide (co2) reagent lot 59384uq03 was identified.

• Brand Name: ALINITY C CARBON DIOXIDE REAGENT KIT
• Type of Device: ENZYMATIC, CARBON-DIOXIDE
• 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: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12685303
• MDR Text Key: 278018175
• Report Number: 3002809144-2021-00616
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740121594
• UDI-Public: 00380740121594
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K060295
• 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: 11/30/2021

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 Expiration Date: 04/30/2022
• Device Model Number: 07P7220
• Device Catalogue Number: 07P72-20
• Device Lot Number: 59384UQ03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 11/18/2021
• Supplement Dates FDA Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, (B)(6).; ALNTY C PROCESSING MODU, 03R67-01, (B)(6).; ALNTY C PROCESSING MODU, 03R67-01, (B)(4)
• Patient Age: 45 YR
• Patient Sex: Male