MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CALCIUM

Model Number N/A

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 identifier: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided by the customer.

Event Description

The customer reported false elevated alinity c calcium results 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 ((b)(6) years- male) sid (b)(6): 16.4 mg/dl, repeats: 8.9, 9.9,10.0, 9.3, 9.3, 9.0, 9.2 mg/dl; on (b)(6) 2020 ((b)(6) years-male) sid (b)(6): 15.1 mg/dl, repeats: 8.6, 9.5, 9.1, 9.3, 9.2, 9.3, 9.3 mg/dl; on (b)(6) 2020 ((b)(6) years-male) sid (b)(6): 15.4, 13.9 gm/dl, repeats: 7.9, 8.2, 8.8, 7.9, 8.1, 8.3 mg/dl; on (b)(6) 2020 ((b)(6) years-female) sid (b)(6): 18.0 mg/dl, repeats: 9.4, 7.3, 8.1, 8.3, 7.9, 9.0, 10.5 mg/dl; on (b)(6) 2020 ((b)(6) years-female) sid (b)(6):14.1 mg/dl, repeats: 9.4, 10.5, 9.9, 9.6, 9.5, 8.0, 9.2 mg/dl; on (b)(6) 2020 ((b)(6) years- female) sid (b)(6): 14.0 mg/dl, repeats: 10.4, 10.3, 10.5, 10.3, 10.3, 9.8, 9.7 mg/dl; on (b)(6) 2020 ((b)(6) years- female) sid (b)(6): 16.9 mg/dl, repeats: 8.8, 8.9, 8.9, 9.1, 9.2 mg/dl.No impact to patient management was reported.

Manufacturer Narrative

Additional information for a.1.Patient identifier (b)(6).Additional information for b5.Describe event or problem the customer provided additional patient results for their report of false elevated alinity c calcium results sid (b)(6) (54 years, female) on (b)(6) 2020: initial = 19.5 mg/dl, repeats = 10.4, 10.4, 10.9, 9.3, 9.0, 9.08 9.33, 11.69, 11.85, 8.6, 10.9 mg/dl.Sid (b)(6) (59 years, female) on (b)(6) 2020 initial = 7.7 repeats = 14.4, 7.5, 9.3 mg/dl.Sid (b)(6) (65 years, female) on (b)(6) 2020 initial = 10.4 mg/dl, repeats = 10.4, 19.5 , 10.9, 9.3, 9.0, 9.08, 9.33, 11.69, 11.85, 8.6, 10.9 mg/dl.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The evaluation of the customers issue included a review of tickets that determined there is normal complaint activity for alinity calcium reagent ln 7p57-30, lot number 37978un19.Trending review determined no trend for discrepant patient results for the product.Return testing was not completed as returns were not available.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 all available information, no product deficiency 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: 10221593
• MDR Text Key: 231304772
• Report Number: 3002809144-2020-00543
• 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
• 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: N/A
• 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: 07/01/2020
• Supplement Dates Manufacturer Received: 07/24/2020; 09/10/2020
• Supplement Dates FDA Received: 08/23/2020; 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY C PROCESSING MODULE; ALINITY C PROCESSING MODULE; ALINITY C PROCESSING MODULE,; LN 03R67-01, SN (B)(6) ; LN 03R67-01, SN (B)(6) ; LN 03R67-01, SN (B)(6)