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 Type  malfunction  

Manufacturer Narrative

All available patient information has been included.No additional patient information is available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a false elevated calcium result when processing on the alinity i.The initial and repeat results for sid (b)(6) were >5 and 2.5, respectively.No impact to patient management was reported.

Manufacturer Narrative

An investigation was performed for the customer issue and included a review of the complaint text, a search for similar complaints, a review of trending data, and a review of labeling.A search by product lot number for other tickets similar to this issue found no similar complaints.The trend review by the product list number did not identify any trends related to this issue.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.

• 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: 8846190
• MDR Text Key: 152939381
• Report Number: 3002809144-2019-00477
• 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
• Report Date: 08/26/2019

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 Catalogue Number: 07P57-20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 07/31/2019
• Supplement Dates Manufacturer Received: 08/23/2019
• Supplement Dates FDA Received: 08/26/2019
• 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; SERIAL AC01047; SERIAL AC01047