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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 3L79-22
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.
 
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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 Key11030598
MDR Text Key241306805
Report Number3002809144-2020-01193
Device Sequence Number1
Product Code CJY
UDI-Device Identifier00380740161491
UDI-Public00380740161491
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 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 Date05/05/2021
Device Model Number3L79-22
Device Catalogue Number03L79-32
Device Lot Number3826UN20
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/24/2020
Initial Date FDA Received12/17/2020
Supplement Dates Manufacturer Received01/14/2021
Supplement Dates FDA Received02/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARC C16K PRC MOD, 03L77-01, C1600071; ARC C16K PRC MOD, 03L77-01, C1600071
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