MAUDE Adverse Event Report: ABBOTT GMBH CARBON DIOXIDE; ENZYMATIC, CARBON-DIOXIDE

Model Number 3L80-22

Device Problem Low Test Results (2458)

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

Event Date 07/04/2023

Event Type  malfunction  

Event Description

The customer observed falsely decreased co2 values for multiple patients on the architect c4000.The samples were repeated on other methods and the results were higher.The following data was provided: sid (b)(6) result = 20 biolis result = 28 istat result = 25; sid (b)(6) result = 16 biolis result = 29 istat result = 27; sid (b)(6) result = 16 biolis result = 29 istat result = 28; sid (b)(6) result = 21 biolis result = 28 istat result = 25; sid (b)(6) result = 21 biolis result = 30 istat result = 26; sid (b)(6) result = 15 biolis result = 23 istat result = 24; sid (b)(6) result = 21 biolis result = 29 istat result = 27; sid (b)(6) result = 18 biolis result = 27 istat result = 25; sid (b)(6) result = 17 biolis result = 25 istat result = 21; sid (b)(6) result = 18 istat result = 26; sid (b)(6) result = 16 biolis result = 24 istat result = 23; sid (b)(6) result = 18 biolis result = 27; sid (b)(6) result = 20 biolis result = 28 istat result = 23; sid (b)(6) result = 20 biolis result = 30 istat result = 25; sid (b)(6) result = 20 biolis result = 28 istat result = 23.Reference range: architect: 22 to 29 meq/l.Biolis: 23 to 34 mmol/l no impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Complete information for section a1 patient identifier: sid (b)(6), sid (b)(6), sid (b)(6), sid (b)(6), sid (b)(6), sid (b)(6), sid (b)(6), sid (b)(6), sid (b)(6), sid (b)(6), sid (b)(6), sid (b)(6), sid (b)(6), sid (b)(6), and sid (b)(6).

Event Description

The customer observed falsely decreased co2 values for multiple patients on the architect c4000.The samples were repeated on other methods and the results were higher.The following data was provided: sid (b)(6)c4000 result = 20 biolis result = 28 istat result = 25 sid (b)(6)c4000 result = 16 biolis result = 29 istat result = 27 sid (b)(6)c4000 result = 16 biolis result = 29 istat result = 28 sid (b)(6)c4000 result = 21 biolis result = 28 istat result = 25 sid (b)(6)c4000 result = 21 biolis result = 30 istat result = 26 sid (b)(6)c4000 result = 15 biolis result = 23 istat result = 24 sid (b)(6)c4000 result = 21 biolis result = 29 istat result = 27 sid (b)(6)c4000 result = 18 biolis result = 27 istat result = 25 sid (b)(6)c4000 result = 17 biolis result = 25 istat result = 21 sid (b)(6)c4000 result = 18 istat result = 26 sid (b)(6)c4000 result = 16 biolis result = 24 istat result = 23 sid (b)(6)c4000 result = 18 biolis result = 27 sid (b)(6)c4000 result = 20 biolis result = 28 istat result = 23 sid (b)(6)c4000 result = 20 biolis result = 30 istat result = 25 sid (b)(6)c4000 result = 20 biolis result = 28 istat result = 23 reference range: architect: 22 to 29 meq/l biolis: 23 to 34 mmol/l no impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for falsely elevated results included a search for similar complaints, and the review of the complaint text, trending data, field data, labelling, and device history records.Return testing was not completed as returns were not available.Historical performance in the field of reagent lots using worldwide data through abbottlink was evaluated.The patient median result for the lot is comparable with all other lots in the field and within established baselines, confirming no systemic issue for the product lot.Trending review determined no trends for the issue for the product.Device history record review on lot 63095uq10 did not show any potential non-conformances, or deviations.Labelling and literature were reviewed which adequately addresses the issue under review.Based on the investigation, no systemic issue or deficiency of the architect carbon dioxide, lot 63095uq10 ln 03l80-22, was identified.

• Brand Name: CARBON DIOXIDE
• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17375247
• MDR Text Key: 320226201
• Report Number: 3002809144-2023-00325
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740161521
• UDI-Public: 00380740161521
• Combination Product (y/n): N
• Reporter Country Code: CJ
• 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: 08/23/2023

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: 11/30/2023
• Device Model Number: 3L80-22
• Device Catalogue Number: 03L80-22
• Device Lot Number: 63095UQ10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 08/21/2023
• Supplement Dates FDA Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4 PROC MOD, 02P24-01, C462451; ARC C4 PROC MOD, 02P24-01, C462451