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

Catalog Number 03L80-31

Device Problem High Test Results (2457)

Patient Problem Coma (2417)

Event Date 02/25/2017

Event Type  Injury  

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

The customer observed a discrepant co2 result on the architect c8000 analyzer.The following data was provided: initial co2 run generated ec 1051 unable to calculate result, absorbance exceeded optical limits.Specimen had 4+ lipemia.Likely cause of 1051 error.System was configured to perform the 1:2 auto-dilution on abs errors.As such, instrument automatically performed the 1:2 dilution which yeilded a <10 result tech then performed a manual 1:5 dilution which yeilded a <25 result.Tech manually reported <25 mmol/l result to emergency dept on feb 25, 2017.The test was repeated as <5 when the patient returned to the emergency room 3 days later in a coma.(note: the package insert states the lower limit of linearity is 5 mmol/l.) retrospective review from the emergency department staff is they believe they would have admitted the patient to the hospital if they had realized the co2 was <10, as <10 is considered a critical value.Since the <25 was reported and normal range is 22-29, the result was overlooked as it was not flagged in their lis or called critical.The patient was discharged from the hospital on (b)(6) 2017, however no further patient details were provided.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, and a review of labeling.The patient sample was not available for return.No adverse trends were identified for the customer's issue.Labeling was reviewed and found to be adequate.No additional information has been provided beyond the following: initial result error code 1051 unable to calculate result, absorbance exceeded optical limits (note: the co2 reagent is configured with system controls to detect samples below the assay linearity low limit of 5 mmol/l.The 4+ lipemic sample generated error code 1051.Per the operations manual, when the customer receives this error code, the sample should be recentrifuged, which was not performed) repeat result automatic 1:2 dilution equal -5.36399 reported as <10.1 2nd repeat result manual 1:5 dilution equal -4.649712 reported out manually by the technician as < 25.0 (note: this result is below the assay linearity low limit of 5 mmol/l) the emergency department performed a retrospective review of the incident.As the normal range for an adult is 22-29 mmol/l, the erroneous reporting of the <25 result due to technician error resulted in discharge of the patient for outpatient treatment.Centrifugation was not performed on the initial result before being repeated.Additionally, the 2nd repeat result was flagged indicating less than the linear low limit, which also should not have been reported before doing the appropriate dilutions.Use error, specifically failure to follow assay specific procedures and protocols, is the cause of this event.Based on all available information and abbott diagnostics' complaint investigation, the product performed as intended and 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
• 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: 6447573
• MDR Text Key: 71322933
• Report Number: 1628664-2017-00087
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740005962
• UDI-Public: (01)00380740005962(17)170930(10)49859UQ08
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 03L80-31
• Device Lot Number: 49859UQ08
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 03/30/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2016
• 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: ARCHITECT C8000 ANALZYER; LN 01G06-11 SN (B)(4)
• Patient Outcome(s): Life Threatening