MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CARBON DIOXIDE

Catalog Number	03L80-31
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a falsely elevated carbon dioxide result on the architect c8000 analyzer.The following data was provided (mmol/l): 1818400847b initial co2 32, repeat 29 there was no impact to patient management reported.
Additional Manufacturer Narrative
On 24july2018, the lot number was provided and updated from unknown to 52577uo02.An evaluation is still in process.A final report will be sent when the evaluation is completed.
Additional Manufacturer Narrative
The incorrect sn was referenced in the concomitant information.The sn was originally reported as ln 01g06-11 sn (b)(6) and it should be ln 01g06-11 sn (b)(6) and was corrected.A new manufacturing report number has been submitted 16september2018 to document this event, suspect medical device change and all evaluation and follow up information in manufacturing report number 1628664-2018-01887.

• Brand Name: CLINICAL CHEMISTRY CARBON DIOXIDE
• Common Device Name: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7704884
• Report Number: 1628664-2018-00281
• Device Sequence Number: 16293790
• Product Code: KHS
• UDI-Device Identifier: 00380740005962
• UDI-Public: 00380740005962
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K060295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2018

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 Catalogue Number: 03L80-31
• Device Lot Number: 52577UO02
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 07/24/2018; 09/12/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 07/24/2018; 09/16/2018
• 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: ARCHITECT C8000 ANALYZER; ARCHITECT C8000 ANALYZER; ARCHITECT C8000 ANALYZER; LN 01G06-11 SN (B)(6); LN 01G06-11 SN (B)(6); LN 01G06-11 SN (B)(6)