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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 Known Impact Or Consequence To Patient (2692)
Event Date 11/16/2020
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A followup report will be submitted when the evaluation is complete.
 
Event Description
The account observed false elevated and imprecise architect calcium results when processing on multiple architect c16000 analyzers, serials (b)(4).Sid (b)(6).Calcium results ranged 3.62 to 3.07 mmol/l.A secondary tube generated calcium results ranged 5.22 to 3.25 mmol/l.Troubleshooting included replacing the sample probe, repeating on additional analyzers with continued imprecise results ranging 2.76 to 2.29 mmol/l.After transferring the specimen to a sample cup for processing results ranging 2.16 to 2.12 mmol/l.Sid (b)(6) generated results of 5.47, 3.22, 3.24, 2.87, 3.27, 1.85, 1.83 mmol/l on serial (b)(4).Sid (b)(6) generated results of 2.83 to 4.13 mmol/l.Sid (b)(6) generated results of 2.85 to 4.08 mmol/l.Sid (b)(6) generated results of 2.44 to 5.20 mmol/l.Sid (b)(6) generated results of 2.96 to 4.22 mmol/l.Sid (b)(6) generated results of 3.20 to 3.71 mmol/l on (b)(6) 2020 on serial (b)(4), but repeated on all 3 architect analyzers ranging from 1.98 to 2.63 mmol/l.No specific patient information was provided.
 
Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for complaint lot.Trending review of complaint product determined no adverse trend for erratic patient results due to the product.Return testing was not completed as returns were not available.Precision study when performed on the instrument using quality controls, was in specification.A review of the manufacturing documentation did not identify any issues associated with the customer observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the evaluation, no systemic issue or product deficiency of architect calcium reagent lot number 38264un20 was identified.
 
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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 Key11055969
MDR Text Key243599551
Report Number3002809144-2020-01205
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 01/28/2021
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
Device Operator Health Professional
Device Expiration Date05/05/2021
Device Model Number3L79-32
Device Catalogue Number03L79-32
Device Lot Number38264UN20
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/30/2020
Initial Date FDA Received12/22/2020
Supplement Dates Manufacturer Received01/08/2021
Supplement Dates FDA Received01/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARC C16K PRC MOD, 03L77-01, C1600070; ARC C16K PRC MOD, 03L77-01, C1600070; ARC C16K PRC MOD, 03L77-01, C1600071, C1600167; ARC C16K PRC MOD, 03L77-01, C1600071, C1600167
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