MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CARBON DIOXIDE REAGENT KIT; ENZYMATIC, CARBON-DIOXIDE

Model Number 07P7220

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2022

Event Type  malfunction  

Event Description

The customer observed falsely decreased co2 results on the alinity c processing module when tubes are processed through track system with average delay of 20 minutes from time of load to processing.When samples are loaded directly onto the alinity c processing module the results are higher.No decreased results were reported out.Abbott field service has been troubleshooting issue and has provided the following data: sid (b)(6) co2 result when front loaded on alinity c and ran immediately = 24 mmol/l.Result when loaded on the track and ran 19 minutes later on same alinity c = 21 mmol/l.Difference = 12.50% no impact to patient management was reported.

Manufacturer Narrative

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

Manufacturer Narrative

The field service representative (fsr) was dispatched for falsely depressed results for co2 when samples are run on the track module and when using alinity c carbon dioxide (co2) reagent ln 7p72-20 lot unknown.Through escalation with global support (gss), a temperature issue was identified on the track and corrected.Repeat results following re-centrifugation and run directly on the instrument are higher than results run on the track directly.The customer performed a study where qc and patient samples were analyzed for co2 immediately and after approximately 20 minutes.The study showed that the drop in results directly correlated to the amount of time the sample was open.A review of tracking and trending of the alinity c carbon dioxide (co2) reagent ln 7p72-20 did not identify any trends associated with the complaint issue.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the complaint information and this investigation, the most likely cause of the lower-than-expected co2 levels is due to extended exposure of the sample to the atmosphere.Labeling advised that 6 mmol/l (average) may be lost per hour once the sample is continuously exposed to the atmosphere.The samples with the higher co2 results were not exposed to the atmosphere like the samples that were not immediately tested after loading.Based on the available information, no malfunction was identified.Based on the information within the complaint record, the device met performance specifications or otherwise performed as intended at the customer site.Use error may have contributed to the customer¿s issue as the samples with lower results were exposed to the atmosphere for an extended period of time.

• Brand Name: ALINITY C CARBON DIOXIDE REAGENT KIT
• Type of Device: ENZYMATIC, CARBON-DIOXIDE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15956093
• MDR Text Key: 305664621
• Report Number: 3002809144-2022-00430
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740121594
• UDI-Public: 00380740121594
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

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 Model Number: 07P7220
• Device Catalogue Number: 07P72-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/10/2022
• Supplement Dates Manufacturer Received: 01/31/2023
• Supplement Dates FDA Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)