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 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information: sample id (b)(6): (b)(6) year old female sample id (b)(6), (b)(6) year old male sample id (b)(6), (b)(6) year old female sample id (b)(6), (b)(6) year old male sample id (b)(6), (b)(6) year old male.No further patient information was provided.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 female: 18.5 mg/dl and normal subsequent results of 8.6 and 8.7 mg/dl.On (b)(6) 2020 - sample id (b)(6), (b)(6) year old male: 15.5 mg/dl and normal subsequent results of 10.0, 9.5, 10.2 and 9.7 mg/dl.On (b)(6) 2020 - sample id (b)(6), (b)(6) year old female: 16.2 mg/dl and normal subsequent results of 9.6 and 9.2 mg/dl.(b)(6) 16.4 mg/dl.On (b)(6) 2020 - sample id (b)(6), (b)(6) year old male: 15.3 and normal subsequent result of 10.3 mg/dl.On (b)(6) 2020 - sample id (b)(6), (b)(6) year old male: 17.0mg/dl, repeat of 7.4 mg/dl and normal subsequent results of 7.9, 8.1 and 7.6 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 ln 7p57-30/lot number 37978un19.Review of trending reports associated with the alinity c calcium assay did not identify any trends for discrepant patient results.Return testing was not completed as returns were not available.Retesting of samples at the customer site generated the 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 c calcium reagent lot number 37978un19 was identified.

• 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: 10199926
• MDR Text Key: 230622531
• Report Number: 3002809144-2020-00532
• 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
• Report Date: 10/28/2020

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: 06/05/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 10/21/2020
• Supplement Dates FDA Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY C PROCESSING MODULE, LIST 03R67-01,; ALNTY C PROCESSING MODU, 03R67-01, (B)(6) ; SERIAL (B)(6)
• Patient Age: 3 YR