MAUDE Adverse Event Report: ABBOTT GMBH CLINICAL CHEMISTRY CARBON DIOXIDE

Model Number N/A

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported false elevated carbon dioxide results while running on the architect c4000 analyzer for 8 patients due to a physician questioning the results.The following data was provided (reference range: 22-29 mmol/l): the initial sample results were tested on (b)(6) 2020 and the repeat sample results were tested on (b)(6) 2020 after replacing the reagent kit with a new reagent kit.Sid (b)(6) = initial = 41 mmol/l, repeat = 22 mmol/l.Sid (b)(6) = initial = 36 mmol/l, repeat = 24 mmol/l.Sid (b)(6) = initial = 45 mmol/l, repeat = 27 mmol/l.Sid (b)(6) = initial = 36 mmol/l, repeat = 23 mmol/l.Sid (b)(6) = initial = 40 mmol/l, repeat = 26 mmol/l.Sid (b)(6) = initial = 34 mmol/l, repeat = 21 mmol/l.Sid (b)(6) = initial = 38 mmol/l, repeat = 26 mmol/l.Sid (b)(6) = initial = 39 mmol/l, repeat = 25 mmol/l.

Manufacturer Narrative

The customer reported falsely elevated results when running co2 (03l80-22) lot 56332uq12 on architect serial number (b)(6).The customer replaced the reagent kit, reran the samples and results were in range.Returns are not available.A review of tickets determined that there is normal complaint activity for lot 56332uq12.Trending review determined no trends identified for false elevated results for the product.The issue appears to be reagent kit specific, customer retested using the same lot and got acceptable results.Device history review identified no nonconformances were found for this current issue.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the co2 reagent, lot number 56332uq12 was identified.

• Brand Name: CLINICAL CHEMISTRY CARBON DIOXIDE
• Type of Device: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10467860
• MDR Text Key: 233891341
• Report Number: 3002809144-2020-00876
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740161521
• UDI-Public: 00380740161521
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

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: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 03L80-22
• Device Lot Number: 56332UQ12
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 09/11/2020
• Supplement Dates FDA Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000 ANALYZER,; ARCHITECT C4000 ANALYZER,; LIST 02P24-40, SERIAL (B)(6); LIST 02P24-40, SERIAL (B)(6)