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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CALCIUM REAGENT KIT; AZO DYE, CALCIUM

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ABBOTT GMBH ALINITY C CALCIUM REAGENT KIT; AZO DYE, CALCIUM Back to Search Results
Model Number 07P5720
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/12/2021
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer reported a false elevated alinity c calcium result for a patient when running on the alinity c processing module.The following data was provided (customer¿s normal range: 8.5 ¿ 10.5 mg/dl): on (b)(6) 2021 = initial calcium result = 16.2 mg/dl, repeated on another alinity analyzer = 9.8, 9.5 mg/dl.There was no impact to patient management reported.
 
Manufacturer Narrative
The complaint investigation for false elevated alinity c calcium results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.A ticket search by lot 81839un21 did not identify an increase in complaint activity for the current issue.Trending was reviewed and did not identify any trends for the product for the issue.The device history record was reviewed, and no non-conformances or deviations were identified.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for alinity c calcium, reagent lot 81839un21 was identified.
 
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Brand Name
ALINITY C CALCIUM REAGENT KIT
Type of Device
AZO DYE, CALCIUM
Manufacturer (Section D)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM  65205
MDR Report Key12436326
MDR Text Key277980258
Report Number3002809144-2021-00560
Device Sequence Number1
Product Code CJY
UDI-Device Identifier00380740132613
UDI-Public00380740132613
Combination Product (y/n)N
PMA/PMN Number
K062855
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/20/2021
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 Date05/08/2022
Device Model Number07P5720
Device Catalogue Number07P57-20
Device Lot Number81839UN21
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/13/2021
Initial Date FDA Received09/07/2021
Supplement Dates Manufacturer Received10/11/2021
Supplement Dates FDA Received10/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
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