MAUDE Adverse Event Report: ABBOTT GMBH CALCIUM; AZO DYE, CALCIUM

Model Number 3L79-32

Device Problem High Test Results (2457)

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

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A followup report will be submitted when the evaluation is complete.

Event Description

The account observed false elevated and imprecise architect calcium results when processing on multiple architect c16000 analyzers, serials (b)(4).Sid (b)(6).Calcium results ranged 3.62 to 3.07 mmol/l.A secondary tube generated calcium results ranged 5.22 to 3.25 mmol/l.Troubleshooting included replacing the sample probe, repeating on additional analyzers with continued imprecise results ranging 2.76 to 2.29 mmol/l.After transferring the specimen to a sample cup for processing results ranging 2.16 to 2.12 mmol/l.Sid (b)(6) generated results of 5.47, 3.22, 3.24, 2.87, 3.27, 1.85, 1.83 mmol/l on serial (b)(4).Sid (b)(6) generated results of 2.83 to 4.13 mmol/l.Sid (b)(6) generated results of 2.85 to 4.08 mmol/l.Sid (b)(6) generated results of 2.44 to 5.20 mmol/l.Sid (b)(6) generated results of 2.96 to 4.22 mmol/l.Sid (b)(6) generated results of 3.20 to 3.71 mmol/l on (b)(6) 2020 on serial (b)(4), but repeated on all 3 architect analyzers ranging from 1.98 to 2.63 mmol/l.No specific patient information was provided.

Manufacturer Narrative

A review of tickets determined that there is normal complaint activity for complaint lot.Trending review of complaint product determined no adverse trend for erratic patient results due to the product.Return testing was not completed as returns were not available.Precision study when performed on the instrument using quality controls, was in specification.A review of the manufacturing documentation did not identify any issues associated with the customer observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the evaluation, no systemic issue or product deficiency of architect calcium reagent lot number 38264un20 was identified.

• Brand Name: CALCIUM
• Type of Device: AZO DYE, CALCIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11055969
• MDR Text Key: 243599551
• Report Number: 3002809144-2020-01205
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740161507
• UDI-Public: 00380740161507
• Combination Product (y/n): N
• PMA/PMN Number: K062855
• 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: 01/28/2021

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: 05/05/2021
• Device Model Number: 3L79-32
• Device Catalogue Number: 03L79-32
• Device Lot Number: 38264UN20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C16K PRC MOD, 03L77-01, C1600070; ARC C16K PRC MOD, 03L77-01, C1600070; ARC C16K PRC MOD, 03L77-01, C1600071, C1600167; ARC C16K PRC MOD, 03L77-01, C1600071, C1600167