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

Catalog Number	03L80-31
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of complaints associated with likely cause lot 48093uq08 found no other complaints.Review of complaints associated with the carbon dioxide assay did not identify any adverse or non-statistical trends.Labeling was reviewed and sufficiently addresses the customer's issue.The patient's lipemic serum was visually described as "milky" or "milkshake".Along with the suspect co2 results, the hil (hemolysis icterus lipemia) results were also provided.These results show extremely elevated semi-quantitative lipemia results of between 5.42 and 7.88.Use error may have contributed to the customer's issue as the extreme lipemia of the sample prevented the assay from producing the correct result.Other assay results, namely the hil indices, advise the operator of a highly lipemic sample and further investigation of the sample is required before producing final results for any photometric analysis.A systemic issue or deficiency was not identified.Additional sample ids (b)(6).
Event or Problem Description
The customer reported falsely depressed co2 results of 11, 8, 13, <5 mmol/l were generated using several architect analyzers with a patient who tested siemens rapid point 500 blood gas analyzer of 24.2 mmol/l.The account uses a normal co2 reference range of 22 to 30 mmol/l.No impact to patient management was reported.

• Brand Name: CLINICAL CHEMISTRY CARBON DIOXIDE
• Common Device Name: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 6548576
• Report Number: 1628664-2017-00185
• Device Sequence Number: 81829
• Product Code: KHS
• UDI-Device Identifier: 00380740005962
• UDI-Public: 00380740005962
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K060295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 03L80-31
• Device Lot Number: 48093UQ08
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2017
• Initial Report FDA Received Date: 05/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AND (B)(4) ; ARCHITECT C16000 LIST 03L77-01; SERIAL (B)(4)
• Patient Age: 32 YR