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 09/26/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer observed falsely depressed co2 results for two patients.The following data was provided (patient reference range: 23 - 31 mmol/l): sid (b)(6): initial 7.0 mmol/l, repeat 24 mmol/l.Sid (b)(6): initial 9 mmol/l, repeat 27 mmol/l no impact to patient management was reported.

Manufacturer Narrative

After further evaluation, the suspect medical device was changed from carbon dioxide, 03l80-22, and manufacturing site in section d of this report (wiesbaden) to architect c4000 instrument, 02p24-40, and manufacturing site of new suspect device (irving, texas).Mdr number 3016438761-2022-00537-00 has been submitted and all further information will be documented under that mdr number.H3 other text : device evaluation in progress.

• 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: 15639168
• MDR Text Key: 303156756
• Report Number: 3002809144-2022-00370
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740161521
• UDI-Public: 00380740161521
• 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: 11/29/2022

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 Model Number: 3L80-22
• Device Catalogue Number: 03L80-22
• Device Lot Number: 62208UQ06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/20/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4000 INTGR, 02P24-40, (B)(6) ; ARC C4000 INTGR, 02P24-40, (B)(6)