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

Model Number 3L80-22

Device Problem High Test Results (2457)

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

Event Date 10/29/2021

Event Type  malfunction  

Event Description

The customer questioned carbon dioxide results for multiple patients.The customer uses the reference range 22-29 mmol/l.The following information was provided: sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.Sid "(b)(4)" initial result (b)(6) mmol/l repeated result (b)(6) mmol/l.No impact to patient management was reported.

Manufacturer Narrative

No patient demographic information was provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

After further evaluation, the suspect medical device was changed from carbon dioxide, list number 03l80-22, manufactured by abbott gmbh in wiesbaden to architect c4000, list number 02p24-40, manufactured by abbott labs in irving.Mdr number 3016438761-2021-00517 has been submitted and all further information will be documented under that mdr number.

• 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: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12816709
• MDR Text Key: 282917560
• Report Number: 3002809144-2021-00649
• 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: 12/13/2021

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: 06/30/2022
• Device Model Number: 3L80-22
• Device Catalogue Number: 03L80-22
• Device Lot Number: 59776UQ05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/15/2021
• Supplement Dates Manufacturer Received: 12/10/2021
• Supplement Dates FDA Received: 12/13/2021
• 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).