MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT CARBON DIOXIDE

Model Number 3L80-32

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2020

Event Type  malfunction  

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 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.

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
• Type of Device: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10476215
• MDR Text Key: 241305825
• Report Number: 3002809144-2020-00878
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740161538
• UDI-Public: 00380740161538
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 09/14/2020
• Supplement Dates FDA Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT 16000 PROCESSING MODULE; ARCHITECT 16000 PROCESSING MODULE; LN 03L77-01, SN (B)(6) ; LN 03L77-01, SN (B)(6)