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

Catalog Number 07P72-20

Device Problem High Test Results (2457)

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

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a1 - patient identifier complete entry = (b)(6) all available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely elevated alinity c carbon dioxide results for five patients.The following data was provided (customer¿s reference range is 22-29 meq/l): sample id (b)(6) initial result was 34, repeat was 29 meq/l sample id (b)(6) initial result was 32, repeat was 26 meq/l sample id (b)(6) initial result was 34, repeat was 29 meq/l sample id (b)(6) initial result was 30, repeat results were 27 and 23 meq/l sample id (b)(6) initial result was 34, repeat was 26 meq/l.There was no impact to patient management reported.

Manufacturer Narrative

Updated section d4 - primary udi number from (b)(4).The complaint investigation for falsely elevated patient results when using alinity c carbon dioxide included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed, as returns were not available.Troubleshooting was performed by rerunning samples on the same lot of reagent and the issue was resolved.The quality controls were within range at the time of the incident.No additional issues were identified.Trending review determined no related trends for the product.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Device history record review on lot number 65006uq10 did not identify any non-conformances or deviations with the likely cause lot.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of alinity c carbon dioxide, lot number 65006uq10, was identified.

Event Description

The customer observed falsely elevated alinity c carbon dioxide results for five patients.The following data was provided (customer¿s reference range is 22-29 meq/l): sample id (b)(6) initial result was 34, repeat was 29 meq/l.Sample id (b)(6) initial result was 32, repeat was 26 meq/l.Sample id (b)(6) initial result was 34, repeat was 29 meq/l.Sample id (b)(6) initial result was 30, repeat results were 27 and 23 meq/l.Sample id (b)(6) initial result was 34, repeat was 26 meq/l.There was no impact to patient management reported.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18906916
• MDR Text Key: 337697742
• Report Number: 3002809144-2024-00074
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740121594
• UDI-Public: (01)00380740121594(17)241130(10)65006UQ10
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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 Catalogue Number: 07P72-20
• Device Lot Number: 65006UQ10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2023
• 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)