MAUDE Adverse Event Report: ALERE SAN DIEGO LDX LIPID PROFILE+GLUCOSE (10T); CHOL/LIPID ANALYZER

Model Number 10-991

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2019

Event Type  malfunction  

Manufacturer Narrative

Results pending the investigation conclusion.

Event Description

It was reported that there was imprecision for tc, hdl, trg and glu on one analyzer, one lot with one patient.There was no report of adverse event.First test (11:14 am):tc=203, hdl=36, trg=n/a, glu<50, second test (11:25 am):tc=323, hdl>100, trg=85, glu=81.Troubleshooting discussion occurred about the possible causes for unexpected results focusing on proper sampling technique and storage conditions per pi-no deviations noted.

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.No deviations were noted regarding technique, storage, or handling based on the information provided.A root cause could not be identified based on the information provided.

Manufacturer Narrative

D4: udi information added.Investigation conclusion: the percent bias was outside of ncep guidelines for total error of [?] 8.9% for tc.The percent coefficient of variation (cv) for the analytes were not calculated due to only having 2 results provided.The remaining analyte results could not be analyzed due to the ldx results being outside of measurable range or displaying n/a.For this reason, it was not possible to determine if the other analytes were performing within specifications.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.No deviations were noted regarding technique, storage, or handling based on the information provided.A root cause could not be identified based on the information provided.

• Brand Name: LDX LIPID PROFILE+GLUCOSE (10T)
• Type of Device: CHOL/LIPID ANALYZER
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 8919017
• MDR Text Key: 192735224
• Report Number: 2027969-2019-00241
• Device Sequence Number: 1
• Product Code: CHH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 10-991
• Device Catalogue Number: 10-991
• Device Lot Number: 418622
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR