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 Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier complete entry = (b)(6).All available patient information was included.Additional patient details are not available.The complaint investigation for falsely elevated patient results when using alinity c carbon dioxide, lot number 57109uq03, and alinity c carbon dioxide calibrator, lot number 86176fd01, 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.Trending review determined no related trend for the product.Manufacturing documentation for the likely cause lots were reviewed and did not identify any issues.Device history record review on lot numbers 57109uq03 and 86176fd01 did not identify any non-conformances or deviations with the likely cause lots.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the alinity c carbon dioxide assay was identified.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of alinity c carbon dioxide was identified.

Event Description

The customer observed falsely elevated alinity c carbon dioxide results for six patients.The following data was provided: sample id (b)(6) initial result was 30, repeat after recalibration was 27 mmol/l.Sample id (b)(6) initial result was 30, repeat after recalibration was 27 mmol/l.Sample id (b)(6) initial result was 30, repeat after recalibration was 27 mmol/l.Sample id (b)(6) initial result was 30, repeat after recalibration was 27 mmol/l.Sample id (b)(6) initial result was 31, repeat after recalibration was 28 mmol/l.Sample id (b)(6) initial result was 30, repeat after recalibration was 27 mmol/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: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 11008036
• MDR Text Key: 241306721
• Report Number: 3002809144-2020-01184
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740121594
• UDI-Public: 00380740121594
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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
• Report Date: 12/14/2020

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: 04/30/2021
• Device Model Number: 07P7220
• Device Catalogue Number: 07P72-20
• Device Lot Number: 57109UQ03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2020
• Initial Date FDA Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1