MAUDE Adverse Event Report: ABBOTT LABORATORIES CARBON DIOXIDE

Model Number 3L80-21

Device Problem High Test Results (2457)

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

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: (b)(6).An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information is included.Additional patient details are not available.

Event Description

The customer reported false elevated architect co2 assay results for three patients.The customer provided: (b)(6) initial = >50 mmol/l, repeat = 27 mmol/l; (b)(6) initial = >50 mmol/l, repeat = 24 mmol/l; (b)(6) initial = >50 mmol/l, repeat 20.3, 20.4 mmol/l (range: 23.0 to 31 mmol/l).There was no impact to patient management reported.

Manufacturer Narrative

The evaluation of the customers issue included a review of tickets determined that there is normal complaint activity for lot 56991uq02.Trending review determined no trend for falsely elevated results ln 03l80-22.Return testing was not completed as returns were not available.Qc results were within range during the time of this occurrence.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.Based on all available information, no product deficiency was identified.

Manufacturer Narrative

On 08sep2020 it was discovered that this submission was filed on the incorrect manufacturing site in section d 3 and section g 1.2.A new emdr, number 3016438761-2020-00206, has been submitted and all further information will be documented under that mdr number.

• Brand Name: CARBON DIOXIDE
• Type of Device: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 10365161
• MDR Text Key: 233018113
• Report Number: 1415939-2020-00117
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740005955
• UDI-Public: 00380740005955
• 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,Followup
• Report Date: 09/10/2020

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: 03/31/2021
• Device Model Number: 3L80-21
• Device Catalogue Number: 03L80-22
• Device Lot Number: 56991UQ02
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/04/2020
• Supplement Dates Manufacturer Received: 08/18/2020; 09/08/2020
• Supplement Dates FDA Received: 09/04/2020; 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000 SYSTEM,; ARCHITECT C4000 SYSTEM,; ARCHITECT C4000 SYSTEM,; LN 02P24-40, SN (B)(4); LN 02P24-40, SN (B)(6); LN 02P24-40, SN (B)(6)