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

Model Number	3L80-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 3002809144-2021-00649
• Device Sequence Number: 11936845
• Product Code: KHS
• UDI-Device Identifier: 00380740161521
• UDI-Public: 00380740161521
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K060295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC C4000 INTGR, 02P24-40, (B)(6) ; ARC C4000 INTGR, 02P24-40, (B)(6).
• Patient Sex: Unknown