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

Model Number	3L79-32
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: sid (b)(6) (too long in length to put in field).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a falsely depressed calcium result for a patient when using the architect c16000 processing module.The following data was provided on (b)(6) 2021: sid (b)(6) = initial result = 0.71 mmol/l, repeat = 2.40 mmol/l (c4 analyzer), repeat on another analyzer in the lab (c3 analyzer) = 2.34 mmol/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from calcium, list number (b)(4) ((b)(6) , germany as manufacturing site) to architect c16000, list number (b)(4) (irving, tx (b)(4) manufacturing site).Mdr number 3016438761-2021-00235-00 has been submitted and all further information will be documented under that mdr number.H3 other text : after further evaluation, the suspect medical device was changed from calcium, list number (b)(4) ((b)(6) , germany.

• 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: 12018058
• Report Number: 3002809144-2021-00384
• Device Sequence Number: 16958919
• Product Code: CJY
• UDI-Device Identifier: 00380740161507
• UDI-Public: 00380740161507
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K062855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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: 01/20/2022
• Device Model Number: 3L79-32
• Device Catalogue Number: 03L79-32
• Device Lot Number: 50855UN20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 06/28/2021
• 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, C1601197; ARC C16K PRC MOD, 03L77-01, C1601197