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

Catalog Number 03L80-21

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2014

Event Type  malfunction  

Event Description

The customer stated that a decreased clinical chemistry co2 result of <5 mmol/l was generated on an extremely lipemic sample.The results were not consistent with the patient history.A blood gas was ordered and the co2 was 24 mmol/l.There was no report of impact to patient management.

Manufacturer Narrative

(b)(4).A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The customer reported a lower than expected carbon dioxide (co2) result for one patient while using carbon dioxide reagent ln 3l80-21 (lot 45501uq01) on the architect c8000 analyzer.The customer reported that the patient sample in question was hemolyzed and extremely lipemic.Customer complaint data was reviewed and no adverse trends for the architect co2 reagent were identified.The architect system operations manual and the co2 reagent package insert were reviewed and were found to adequately address the issue.A literary search for articles specific to this issue of lipid interference and lower than expected co2 results found lipemia to be a known interferant for photometric assays and not specific to abbott's co2 assay which uses an enzymatic spectrophotometric methodology.Although no specific reason can be identified for this issue, the lower than expected co2 results could be due to either the interference with the photometric analysis by the light scattering effect of the lipids or volume displacement of the plasma by the lipids.The investigation did not identify a malfunction / deficiency.

• Brand Name: CLINICAL CHEMISTRY CARBON DIOXIDE
• Type of Device: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 4133419
• MDR Text Key: 4937160
• Report Number: 1628664-2014-00215
• Device Sequence Number: 1
• Product Code: KHS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K060295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/10/2014

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: 02/28/2015
• Device Catalogue Number: 03L80-21
• Device Lot Number: 45501UQ01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/22/2014
• Initial Date FDA Received: 10/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SN(B)(4); ARCHITECT C8000 ANALYZER 1G06-01
• Patient Age: 50 YR