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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH CALCIUM; AZO DYE, CALCIUM
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ABBOTT GMBH CALCIUM; AZO DYE, CALCIUM Back to Search Results
Model Number 3L79-32
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/21/2021
Event Type  malfunction  
Manufacturer Narrative
Patient identifier = (b)(6).All available patient information was included.No additional information was provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer reported falsely elevated calcium results were generated for a patient on the architect c16000 analyzer.The customer stated on (b)(6) 2021 sid (b)(6) generated an initial result of 19.10 mg/dl, with a repeat result of 9.33 mg/dl.There was no reported impact to patient management.
 
Manufacturer Narrative
After further evaluation, the suspect medical device was changed from calcium, list 03l79-32, (b)(6) germany.To the architect c16000, (b)(6) texas.Usa.Mdr number 3016438761-2021-00214 has been submitted and all further information will be documented under that mdr number.
 
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Brand Name
CALCIUM
Type of Device
AZO DYE, CALCIUM
Manufacturer (Section D)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM  65205
MDR Report Key11930396
MDR Text Key254057531
Report Number3002809144-2021-00349
Device Sequence Number1
Product Code CJY
UDI-Device Identifier00380740161507
UDI-Public00380740161507
Combination Product (y/n)N
PMA/PMN Number
K062855
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 06/14/2021
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 Model Number3L79-32
Device Catalogue Number03L79-32
Device Lot Number90569UN20
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/21/2021
Initial Date FDA Received06/03/2021
Supplement Dates Manufacturer Received06/08/2021
Supplement Dates FDA Received06/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARC C16K PRC MOD, 03L77-01, C1600446; ARC C16K PRC MOD, 03L77-01, C1600446; ARC C16K PRC MOD, 03L77-01, C1600446
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