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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ALINITY C CALCIUM

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ABBOTT MANUFACTURING INC ALINITY C CALCIUM Back to Search Results
Catalog Number 07P57-20
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/23/2018
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.An evaluation is in process.
 
Event Description
The customer observed falsely elevated results while using alinity c calcium reagents.The following data was provided.The customer uses normal range 2.20 to 2.55 mmol/l and results greater than 4.00 mmol/l are checked.Initial 3.84 mmol/l, repeat 2.55, 2.60 mmol/l the patient was hospitalized when the value in the normal range was obtained.No adverse impact to patient management was reported.
 
Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, and a review of labeling.Return material was not available from the customer.Based on the available data, it appears that a sample aspiration issue was present.A review of tracking and trending did not identify an adverse trend for issue observed by the customer.No other similar complaints were identified with this reagent lot number.Labeling was reviewed and found to be adequate.Based on this investigation this appears to be a sample specific issue.Based on the available information no deficiency of the alinity c calcium reagent (ln 7p57-20) , lot 32858un18 , was identified.
 
Manufacturer Narrative
Suspect medical device: catalog number was changed to ln 07p57-20 from ln 07p57-30 and the udi number (gtin) was changed to (b)(4) from (b)(4).The lot number was not changed.An evaluation is in process.
 
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Brand Name
ALINITY C CALCIUM
Type of Device
CALCIUM
Manufacturer (Section D)
ABBOTT MANUFACTURING INC
1921 hurd drive
irving TX 75038
MDR Report Key8172021
MDR Text Key131001779
Report Number1628664-2018-02150
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 foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 03/08/2019
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 Date02/12/2019
Device Catalogue Number07P57-20
Device Lot Number32858UN18
Initial Date Manufacturer Received 11/26/2018
Initial Date FDA Received12/17/2018
Supplement Dates Manufacturer Received12/26/2018
02/15/2019
Supplement Dates FDA Received01/04/2019
03/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALINITY C ANALYZER; ALINITY C ANALYZER; ALINITY C ANALYZER; LN 03R67-01 SN (B)(4); LN 03R67-01 SN (B)(4); LN 03R67-01 SN (B)(4)
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