MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CALCIUM

Model Number 07P5730

Device Problem High Test Results (2457)

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

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer obtained a falsely elevated alinity c calcium result for multiple patients.The customer uses a normal range of 8.5 to 10.5 mg/dl.The following results were provided: on (b)(6) 2020 sample id (b)(6), (b)(6) year old male: 15.4 mg/dl, repeat 8 mg/dl and subsequent result of 8.3 mg/dl.On (b)(6) 2020 sample id (b)(6), (b)(6) year old male: 16.3 mg/dl and normal subsequent results that ranged from 7.7 to 8.7 mg/dl.On (b)(6) 2020 sample id (b)(6), (b)(6) year old male: 15.9 mg/dl and normal subsequent results that ranged from 8.2 to 9.2 mg/dl.On (b)(6) 2020 sample id (b)(6), (b)(6) year old male: 14.7 mg/dl and normal subsequent results that ranged from 7.6 to 7.9 mg/dl.On (b)(6) 2020 sample id (b)(6), male: 15.1 mg/dl and the previous result was 9.9 mg/dl no impact to patient management was reported.

Manufacturer Narrative

A review of tickets determined that there is normal complaint activity for alinity calcium reagent lot number 37978un19.Trending data for the alinity c calcium assay was reviewed and determined there were no trend for discrepant patient results.Return testing was not completed as returns were not available.Review of data provided by the customer indicates retesting of the samples on the same instrument gave expected results.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the alinity calcium reagent lot number 37978un19 was identified.

Manufacturer Narrative

An additional discrepant result was provided on (b)(6)2020.The new information was added to section b5.An evaluation is still in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

On (b)(6)2020 an additional falsely elevated alinity c calcium result was provided.Sample id 23954659 for a 67 year old female generated 14.9 and repeat of 9.6 mg/dl which matched the patient's previous results.

Manufacturer Narrative

On (b)(6)2020 the reagent lot in use was provided.Section d4 lot# was changed from unknown to (b)(6)2019.No other updates were needed.An evaluation is still in process.A follow-up report will be submitted when the evaluation is complete.

• Brand Name: ALINITY C CALCIUM
• Type of Device: CALCIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10209082
• MDR Text Key: 230614171
• Report Number: 3002809144-2020-00536
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740135409
• UDI-Public: 00380740135409
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/16/2020

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 Expiration Date: 07/23/2020
• Device Model Number: 07P5730
• Device Catalogue Number: 07P57-30
• Device Lot Number: 37978UN19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 06/29/2020
• Supplement Dates Manufacturer Received: 07/07/2020; 08/03/2020; 09/10/2020
• Supplement Dates FDA Received: 07/28/2020; 08/19/2020; 09/16/2020
• 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,; ALINITY C PROCESSING MODULE, LIST 03R67-01,; SERIAL (B)(6); SERIAL (B)(6); SERIAL NUMBER (B)(6); SERIAL NUMBER (B)(6)