MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C ALKALINE PHOSPHATASE REAGENT KIT; NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES

Catalog Number	08P20-30
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed alkaline phosphatase ifcc (international federation of clinical chemistry) conversion factor not entered in assay parameter setting by the abbott field service representative (fsr), at the time of multiple alinity ci processing modules setup.The customer requested ifcc method for alkaline phosphatase on alinity ci processing module since (b)(6) 2022 during the time of alinity ci setup.The alkaline phosphatase ifcc should have calibration factor 2290 and non-ifcc calibration factor 2150.The customer noticed the non-ifcc calibration factor 2150 when doing new alkaline phosphatase reagent calibration, at that time find out about this issue.There should be conversion factor on assay parameter setting when select unit of measure then need to enter conversion factor 1.0651 for ifcc method and that was not entered by the fsr at the time of setup of alinity ci processing module.There was no information provided by the customer for discrepant alkaline phosphatase results.There was no treatment changed due to discrepant alkaline phosphatase results reported.No further impact to patient management reported.
Additional Manufacturer Narrative
The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review of alinity c alkaline phosphatase, list number 08p20-30, lot 00647un23.The trending report review determined that there are no trends for the product for the complaint issue.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the likely cause lot(s) and complaint issue.The ticket search determined that there is as expected complaint activity for the likely cause lot 00647un23.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.There was no issue with reagent performance identified.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity c alkaline phosphatase lot number 00647un23.
Event or Problem Description
The customer observed alkaline phosphatase ifcc (international federation of clinical chemistry) conversion factor not entered in assay parameter setting by the abbott field service representative (fsr), at the time of multiple alinity ci processing modules setup.The customer requested ifcc method for alkaline phosphatase on alinity ci processing module since 15feb2022 during the time of alinity ci setup.The alkaline phosphatase ifcc should have calibration factor 2290 and non-ifcc calibration factor 2150.The customer noticed the non-ifcc calibration factor 2150 when doing new alkaline phosphatase reagent calibration, at that time find out about this issue.There should be conversion factor on assay parameter setting when select unit of measure then need to enter conversion factor 1.0651 for ifcc method and that was not entered by the fsr at the time of setup of alinity ci processing module.There was no information provided by the customer for discrepant alkaline phosphatase results.There was no treatment changed due to discrepant alkaline phosphatase results reported.No further impact to patient management reported.

• Brand Name: ALINITY C ALKALINE PHOSPHATASE REAGENT KIT
• Common Device Name: NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES
• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18597883
• Report Number: 3002809144-2024-00022
• Device Sequence Number: 6811129
• Product Code: CJE
• UDI-Device Identifier: 00380740135171
• UDI-Public: 00380740135171
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K023807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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: 04/06/2024
• Device Catalogue Number: 08P20-30
• Device Lot Number: 00647UN23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY C PROCESSING MODU, 03R67-01, AC04170; ALNTY C PROCESSING MODU, 03R67-01, AC04170; ALNTY C PROCESSING MODU, 03R67-01, AC04224; ALNTY C PROCESSING MODU, 03R67-01, AC04224; ALNTY C PROCESSING MODU, 03R67-01, AC04225; ALNTY C PROCESSING MODU, 03R67-01, AC04225; ALNTY C PROCESSING MODU, 03R67-01, AC04289; ALNTY C PROCESSING MODU, 03R67-01, AC04289
• Patient Sex: Unknown