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

Catalog Number 03L80-31

Device Problem High Test Results (2457)

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

Event Date 09/12/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer observed falsely elevated co2 results while using the clinical chemistry co2 assay.The customer provided the following data for 4 patients (normal range is 23-31 meq/l): sid (b)(6): initial 32 meq/l, retested using new reagent 27 meq/l.Sid (b)(6): initial 35 meq/l, retested using new reagent 29 meq/l.Sid (b)(6): initial 32 meq/l, retested using new reagent 27 meq/l.Sid (b)(6): initial 31 meq/l, retested using new reagent 27 meq/l.No impact to patient management was reported.No additional patient information was provided.

Manufacturer Narrative

An evaluation of the customer issue included a review of the complaint text, review of technical bulletin, a search for similar complaints, and a review of labeling.Return material was not available.The technical bulletin was reviewed and provided adequate troubleshooting specifying how reagent handling, exposure to air, and water quality may also impact co2 results.Tracking and trending did not identify an adverse trend.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency of the clinical chemistry co2 reagent list number 03l80, lot number 52577uq02, was identified.

Manufacturer Narrative

An evaluation is in-process.

• 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: 7914125
• MDR Text Key: 123533587
• Report Number: 1628664-2018-01916
• 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,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 03L80-31
• Device Lot Number: 52577UQ02
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C16000 SYSTEM; ARCHITECT C16000 SYSTEM; ARCHITECT C16000 SYSTEM; LN 03L77-01, SN (B)(4); LN 03L77-01, SN (B)(4); LN 03L77-01, SN (B)(4)