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

Catalog Number 03L80-21

Device Problem High Test Results (2457)

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

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported multiple architect carbon dioxide results that were either falsely elevated or repeated lower when rerun.The customer provided the following discrepant results: initial 36, repeat 20 discrepant; initial 25, repeat 18 discrepant; initial 27, repeat 18 discrepant; initial 36, repeat 23 discrepant; initial 41, repeat 20 discrepant; initial 32, repeat 27 discrepant; initial 25, repeat 21 discrepant; initial 31, repeat 27 discrepant; initial 27, repeat 21 discrepant; initial 24, repeat 19 discrepant.The customer uses a normal range of 22-29 mmol/l.No impact to patient management was reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint, a search for similar complaints, a review for complaint trends, a review of labeling.A search for similar complaint was performed for reagent lot 53082uq05 found no other complaint similar to the complaint issue.No non-statistical or adverse trend, non-conformances, potential non-conformances, or deviations were identified for the customer's issue.The original sample was retested and generated lower results.After troubleshooting no additional discrepant results were generated.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• Brand Name: CLINICAL CHEMISTRY CARBON DIOXIDE
• Type of Device: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8191268
• MDR Text Key: 131798626
• Report Number: 1628664-2018-02173
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740005955
• UDI-Public: 00380740005955
• Combination Product (y/n): N
• PMA/PMN Number: K060295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

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: 06/30/2019
• Device Catalogue Number: 03L80-21
• Device Lot Number: 53082UQ05
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 02/06/2019
• Supplement Dates FDA Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C8000 SYSTEM, LN 01G06-11; ARCHITECT C8000 SYSTEM, LN 01G06-11; SN (B)(4); SN (B)(4)