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

Model Number	3L79-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: AZO DYE, CALCIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11030598
• Report Number: 3002809144-2020-01193
• Device Sequence Number: 1307868
• Product Code: CJY
• UDI-Device Identifier: 00380740161491
• UDI-Public: 00380740161491
• 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): 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
• Operator of Device: 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 Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 02/05/2021
• 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, C1600071; ARC C16K PRC MOD, 03L77-01, C1600071