MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CALCIUM REAGENT KIT; AZO DYE, CALCIUM

Catalog Number	07P57-20
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
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 falsely decreased calcium results on alinity c processing module for one patient.The results provided were: on (b)(6) 2023, (b)(6) from lithium heparin plasma specimen=4.8 mg/dl.The patient sends to er due to falsely decreased alinity calcium results.The patient was redrawn and repeated in er on ortho=9.3 mg/dl on (b)(6) 2023 initial specimen (b)(6) repeated on same analyzer=9.7 mg/dl and 9.4 mg/dl laboratory reference range for calcium=8.6 to 10.3 mg/dl.The patient did not receive any treatment in emergency room.The patient discharged from emergency room after receiving normal calcium results on ortho analyzer.No further impact to patient management.
Event or Problem Description
The customer observed falsely decreased calcium results on alinity c processing module for one patient.The results provided were: on (b)(6) 2023, sid (b)(6) from lithium heparin plasma specimen=4.8 mg/dl the patient sends to er due to falsely decreased alinity calcium results.The patient was redrawn and repeated in er on ortho=9.3 mg/dl on (b)(6) 2023, initial specimen sid (b)(6) repeated on same analyzer=9.7 mg/dl and 9.4 mg/dl laboratory reference range for calcium=8.6 to 10.3 mg/dl the patient did not receive any treatment in emergency room.The patient discharged from emergency room after receiving normal calcium results on ortho analyzer.No further impact to patient management.
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 and field data of alinity c calcium reagent lot 02298un23.A review of complaints determined that there are no trends for the product for the complaint issue.A review of tickets determined there is as expected complaint activity for lot number 02298un23.Return testing was not completed as returns were not available.Historical performance of reagent lot 02298un23 were evaluated using worldwide data from abbottlink.The median value for normal population results for the lot is within established baselines and comparable with all other lots in the field.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the alinity c calcium assay for lot 02298un23 was identified.

• Brand Name: ALINITY C CALCIUM REAGENT KIT
• Common Device Name: AZO DYE, CALCIUM
• 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: 17452234
• Report Number: 3002809144-2023-00343
• Device Sequence Number: 15299594
• Product Code: CJY
• UDI-Device Identifier: 00380740132613
• UDI-Public: 00380740132613
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K062855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2024
• Device Catalogue Number: 07P57-20
• Device Lot Number: 02298UN23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
• Patient Sex: Unknown