MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT CARBON DIOXIDE

Model Number	3L80-32
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: (b)(6).All available patient information is included.Additional patient details are not available.An evaluation is in process.A follow up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely depressed architect co2 results for four patients.The customer alleges having to issue about 500 corrected co2 reports.However, no data is available for this allegation.The customer did provide information for four patients: pt#1 (b)(6): initial = 16 mmol/l, repeat = 22 mmol/l; pt# 2: (b)(6)initial = 20 mmol/l, repeat = 27 mmol/l; pt#3: (b)(6): initial = 14 mmol/l, repeat = 25 mmol/l; pt#4: (b)(6): initial = 16 mmol/l, repeat = 25 mmol/l (normal range: 20-29 mmol/l).There was no impact to patient management reported.
Additional Manufacturer Narrative
The evaluation of the customers issue included a review of tickets for carbon dioxide (co2) ln 3l80 lot 56883uq02, and trending review.The ticket review determined that there is normal complaint activity for this lot.The trending review determined no trend for falsely depressed results for the product.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Return testing was not completed as returns were not available.Data was provided fregarding the patient sample where the sample was retested by thecustimer, and acceptable results were produced.Based on all available information, no product deficiency was identified.

• Brand Name: ARCHITECT CARBON DIOXIDE
• Common Device Name: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10476215
• Report Number: 3002809144-2020-00878
• Device Sequence Number: 16786004
• Product Code: KHS
• UDI-Device Identifier: 00380740161538
• UDI-Public: 00380740161538
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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
• Report Date (Section B): 09/18/2020

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: 03/31/2020
• Device Model Number: 3L80-32
• Device Catalogue Number: 03L80-32
• Device Lot Number: 56883UQ02
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 09/18/2020
• 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 16000 PROCESSING MODULE; ARCHITECT 16000 PROCESSING MODULE; LN 03L77-01, SN (B)(6) ; LN 03L77-01, SN (B)(6)