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

Model Number	3L79-32
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Event or Problem 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.
Additional 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
• Common Device Name: AZO DYE, CALCIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11055969
• Report Number: 3002809144-2020-01205
• Device Sequence Number: 2651718
• Product Code: CJY
• UDI-Device Identifier: 00380740161507
• UDI-Public: 00380740161507
• Combination Product (Y/N): N
• PMA/510(K) Number: K062855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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