MAUDE Adverse Event Report: ALERE SAN DIEGO LDX LIPID PROFILE+GLUCOSE; LIPID TEST

Model Number	10-991
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results pending completion of the investigation.
Event or Problem Description
On (b)(6) 2020 a patient having a wellness check had a discrepancy with ldx results displaying n/a, specifically tc, non hdl, tc/hdl and ldl.The test was rerun with the same sample and lot although a different cassette with different results.There was no lab/confirmatory testing provided.(all results in mg/dl).There was no adverse event reported.Although requested, no further information has been provided.Test 1: tc:n/a; trg:289; hdl:<15; non-hdl: n/a; tc/hdl: n/a; ldl: n/a; glucose:178 test 2: tc:166; trg: 186; hdl: 51; non-hdl: not provided; tc/hdl: not provided; ldl: 78; glucose:64.
Additional Manufacturer Narrative
A2: age 51 years, dob: (b)(6) 1969.A4: 193.00 pounds.A5: not hispanic/latino.A6: white.B7: relevant history of diabetes, high cholesterol, high blood pressure.H6: type of investigation: 4110.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 lot 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.A probable root cause could not be determined based on the available information.Complaints are tracked and trended on a monthly basis.The ldx analyzer displays n/a when a result cannot be interpreted.See additional limitations that display n/a in the limitations section of the alere cholestech ldx test cassette package insert for additional information.If the n/a result is not expected, the patient can be retested on a new cassette or an alternate method may be used.
Additional Manufacturer Narrative
Additional exerpt to the previously provided investigation conclusion: the bias between the two sets of ldx results was outside the ncep guidelines for trg and glu.Limited information regarding the event was provided, therefore a root cause could not be identified.However, it is possible that storage, handling, and/or technique errors may have contributed to the n/a results, as well as potential erroneous results.

• Brand Name: LDX LIPID PROFILE+GLUCOSE
• Common Device Name: LIPID TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9975 summers ridge rd; san diego CA 92121
• MDR Report Key: 10993890
• Report Number: 2027969-2020-00085
• Device Sequence Number: 690804
• Product Code: JJE
• UDI-Device Identifier: 00893038002654
• UDI-Public: (01)00893038002654(17)211031(10)424872(11)201005
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K120615
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 10-991
• Device Catalogue Number: 10-991
• Device Lot Number: 424872
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 01/15/2021; 03/15/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 01/18/2021; 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 88