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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CALCIUM REAGENT KIT

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ABBOTT GMBH ALINITY C CALCIUM REAGENT KIT Back to Search Results
Model Number 07P5730
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/03/2020
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identifier complete entry = (b)(6).All available patient information was included.Additional patient details are not available.
 
Event Description
The customer observed falsely elevated calcium results for several patients on an alinity c analyzer.The following data was provided (customer's normal range is 8.5-10.5 mg/dl): sample id (b)(6) initial result, on (b)(6) 2020, was 15.3, repeat was 8.1 mg/dl.Sample id (b)(6) initial result, on (b)(6) 2020, was 14.1, repeat was 9.1 mg/dl.Sample id (b)(6) initial result, on (b)(6) 2020, was 14.7, repeat was 9.8 mg/dl.Sample id (b)(6) initial result, on (b)(6) 2020, was 14.4, repeat was 6.5 mg/dl.Sample id (b)(6) initial result, on (b)(6) 2020, was 16.0, repeat was 7.8 mg/dl.There was no impact to patient management reported.
 
Manufacturer Narrative
The complaint investigation for falsely elevated alinity c calcium results included a review of data provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.A review of tickets determined that there is normal complaint activity for alinity c calcium reagent ln 7p57-30/lot number 37978un19.Trending review determined no related trend for the issue for the product.Return testing was not completed, as returns were not available.Review of the capa database found no issue related to the current complaint.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics' complaint investigation, no systemic issue or deficiency of alinity c calcium reagent ln 7p57-30/lot number 37978un19 was identified.An initial report was submitted under manufacturer report number 3016438761-2020-00210 with abbott laboratories (irving ia/cc) 1915 hurd drive irving, tx 75038 as the manufacturing site, however, that is the incorrect manufacturing site.The correct manufacturing site is weisbaden, germany, which is this report.
 
Manufacturer Narrative
The correct manufacturing site for suspect medical device calcium is abbott laboratories (irving ia/cc) 1915 hurd drive irving, tx 75038 and was submitted under manufacturer report number 3016438761-2020-00210.All further information will be documented under mdr number 3016438761-2020-00210.
 
Manufacturer Narrative
Additional patient data provided by customer on 03jul2020 was added to section b5.
 
Event Description
The customer observed falsely elevated calcium results for several patients on an alinity c analyzer.The following data was provided (customer's normal range is 8.5-10.5 mg/dl): sample id (b)(6) initial result, on (b)(6) 2020, was 15.3, repeat was 8.1 mg/dl sample id (b)(6) initial result, on (b)(6) 2020, was 14.1, repeat was 9.1 mg/dl sample id (b)(6) initial result, on (b)(6) 2020, was 14.7, repeat was 9.8 mg/dl sample id (b)(6) initial result, on (b)(6) 2020, was 14.4, repeat was 6.5 mg/dl sample id (b)(6) initial result, on (b)(6) 2020, was 16.0, repeat was 7.8 mg/dl on 03jul2020, the customer provided additional patient data: sample id (b)(6) initial result, on (b)(6) 2020, was 14.9, repeat was 8.9 mg/dl.There was no impact to patient management reported.
 
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Brand Name
ALINITY C CALCIUM REAGENT KIT
Type of Device
CALCIUM
Manufacturer (Section D)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM  65205
MDR Report Key10219230
MDR Text Key199852816
Report Number3002809144-2020-00542
Device Sequence Number1
Product Code CJY
UDI-Device Identifier00380740135409
UDI-Public00380740135409
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 09/14/2020
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 Date07/23/2020
Device Model Number07P5730
Device Catalogue Number07P57-30
Device Lot Number37978UN19
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/11/2020
Initial Date FDA Received07/01/2020
Supplement Dates Manufacturer Received07/03/2020
09/10/2020
09/10/2020
Supplement Dates FDA Received07/28/2020
09/11/2020
09/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALINITY C PROCESSING MODULE, LIST# 03R67-01,; ALINITY C PROCESSING MODULE, LIST# 03R67-01,; ALINITY C PROCESSING MODULE, LIST# 03R67-01,; ALINITY C PROCESSING MODULE, LIST# 03R67-01,; SERIAL# AC02354; SERIAL# AC02354; SERIAL# AC02354; SERIAL# AC02354
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