MAUDE Adverse Event Report: ABBOTT GERMANY ALINITY C CALCIUM

Catalog Number 07P57-20

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.Patient identifier: complete entry is (b)(6).An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

The customer reported falsely elevated alinity c calcium results across three alinity c analyzers.The customer indicated they use a therapeutic range of less than or equal to 2.85 mmol/l the following results were provided: sample id (b)(6): generated results of 3.51, 3.52 and 2.97 mmol/l across three, alinity analyzers.Following recentrifuge 2.91, 2.90 and 2.85 mmol/l, second sample: generated 2.85, 2.71, 2.76 and 2.79 mmol/l, no impact to patient management was reported.

Manufacturer Narrative

The reagent lot was provided and section d suspect medical device, cataloge #, lot # and udi # fields were updated to reflect this change.No other corrections were required.Review of complaint activity for lot 6032un18 identified four other complaints for this customer documenting the current complaint issue.Aside from the current issue an increase in complaint activity was not identified.Tracking and trending report review for the alinity c calcium assay did not identify any trends.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the alinity c calcium assay was identified.

Manufacturer Narrative

The reagent was corrected to 07p57-20 and section d4 cataloge # and udi # fields were updated to reflect this change.No other corrections were required.

• Brand Name: ALINITY C CALCIUM
• Type of Device: CALCIUM
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 8927390
• MDR Text Key: 189349241
• Report Number: 3002809144-2019-00526
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740132613
• UDI-Public: 00380740132613
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2019
• Device Catalogue Number: 07P57-20
• Device Lot Number: 63032UN18
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/23/2019
• Supplement Dates Manufacturer Received: 09/06/2019; 09/20/2019
• Supplement Dates FDA Received: 09/18/2019; 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY C PROCESSING MODULE, LIST 03R67-01,; ALINITY C PROCESSING MODULE, LIST 03R67-01,; ALINITY C PROCESSING MODULE, LIST 03R67-01,; SERIAL AC01873, AC01872 AND AC01401; SERIAL AC01873, AC01872 AND AC01401; SERIAL AC01873, AC01872 AND AC01401