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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. LDX MULTI-ANALYTE CONTROLS (L1 AND L2); CHOLESTECH LDX MULTIANALYTE CONTROLS
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ALERE SAN DIEGO, INC. LDX MULTI-ANALYTE CONTROLS (L1 AND L2); CHOLESTECH LDX MULTIANALYTE CONTROLS Back to Search Results
Model Number 88773
Device Problem Use of Device Problem (1670)
Patient Problem Needle Stick/Puncture (2462)
Event Date 02/13/2023
Event Type  Injury  
Manufacturer Narrative
Results pending completion of the investigation.Although requested, return of device is not anticipated.
 
Event Description
The customer reported they had stuck their finger with a needle from their facility that was being used to draw up the ldx multianalyte control (mac) solution from the vial.The customer reported they used the needle to draw the sample as pipettes are not sufficient for drawing the multianalyte control solution.Technical services advised that the packet insert indicates the multianalyte control should be collected using a pipette and pipette tip.The customer reported no irritation or adverse events.No further information was provided by the customer.
 
Manufacturer Narrative
Investigation conclusion: the case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Batch record review found no relevant non-conformances; the lots met all final release specifications.Review of the risk documents for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.The customer reported that they poked their finger with a syringe needle that contained ldx controls.They were using the syringe in place of a minipet because they felt that these did not draw up sample adequately.Ts advised the customer that they should use the minipet as instructed and provided the sds for the product.The cause of the exposure was related to the customer not following the instructions for use.Per the package insert for the mac controls: materials required but not provided.Pipette for the required volume of controls and pipette tips.Test procedure.Use a pipette for the required volume of controls specified in the test cassette package insertd7a - single use device previously submitted as "na" and is being updated to "no" h3 other text : although requested, return of device is not anticipated.
 
Event Description
The customer reported they had stuck their finger with a needle from their facility that was being used to draw up the ldx multianalyte control (mac) solution from the vial.The customer reported they used the needle to draw the sample as pipettes are not sufficient for drawing the multianalyte control solution.Technical services advised that the packet insert indicates the multianalyte control should be collected using a pipette and pipette tip.The customer reported no irritation or adverse events.No further information was provided by the customer.
 
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Brand Name
LDX MULTI-ANALYTE CONTROLS (L1 AND L2)
Type of Device
CHOLESTECH LDX MULTIANALYTE CONTROLS
Manufacturer (Section D)
ALERE SAN DIEGO, INC.
9942 mesa rim rd
san diego CA 92121
Manufacturer Contact
monika burrell
9942 mesa rim rd
san diego, CA 92121
8588052506
MDR Report Key16512999
MDR Text Key310993897
Report Number2027969-2023-00017
Device Sequence Number1
Product Code JJY
UDI-Device Identifier00899722002849
UDI-Public(01)00899722002849(10)902949956
Combination Product (y/n)N
PMA/PMN Number
K904784
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/29/2023
Device Model Number88773
Device Catalogue Number88773
Device Lot Number902949956
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/13/2023
Initial Date FDA Received03/09/2023
Supplement Dates Manufacturer Received05/26/2023
Supplement Dates FDA Received06/14/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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