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

Model Number 3L79-22

Device Problem High Test Results (2457)

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

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information is included.Additional patient details are not available.

Event Description

The customer reported false elevated architect calcium results for one patient.The initial information from the customer provided: (b)(6) initial = 3.00 mmol/l, repeat = 2.21 mmol/l (reference range 2.10 to 2.55 mmol/l).On (b)(6) 2020 the customer provided additional results for of (b)(6), which ranged from 2.06 mmol/l to 4.40 mmol/l.There was no reported impact to patient management.

Manufacturer Narrative

The evaluation of the customer¿s issue included a search for similar complaints, trending data, device history records, labeling and historical performance of reagent lot review 38264un20.A review of tickets determined that there is normal complaint activity for lot number 38264un20.Trending review of list number 3l79 determined no trend for erratic patient results due to the product.Return testing was not completed as returns were not available.Transferring the sample to a sample cup produced acceptable result.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 architect calcium reagent (ln 3l79-32) lot number 38264un20 was identified.A review of tracking and trending data did not identify an increase in complaint activity related to the current complaint issue.Based on all available information no systemic issue or product deficiency was identified.D4 - catalog no: changed from 03l79-22 to 03l79-32 d4 - unique identifier (udi) #: changed from 00380740161491 to 00380740161507 d4 - lot no: changed from unknown to 3826un20.

• 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: 11030598
• MDR Text Key: 241306805
• Report Number: 3002809144-2020-01193
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740161491
• UDI-Public: 00380740161491
• 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: 02/05/2021

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: 3L79-22
• Device Catalogue Number: 03L79-32
• Device Lot Number: 3826UN20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C16K PRC MOD, 03L77-01, C1600071; ARC C16K PRC MOD, 03L77-01, C1600071