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

Catalog Number 03L80-31

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2016

Event Type  malfunction  

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 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
• 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: 6548576
• MDR Text Key: 74661079
• Report Number: 1628664-2017-00185
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740005962
• UDI-Public: 00380740005962
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K060295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 03L80-31
• Device Lot Number: 48093UQ08
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2017
• Initial Date FDA Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: AND (B)(4) ; ARCHITECT C16000 LIST 03L77-01; SERIAL (B)(4)
• Patient Age: 32 YR