MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. KIT,TRIAGE, CARDIAC TNI / CKMB; CARDIAC MARKER TEST

Model Number 97022HS

Device Problems Device Issue (2379); Incorrect Or Inadequate Test Results (2456)

Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)

Event Date 08/24/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: customer's complaint of discrepant low was not replicated with in-house testing of retain lot w60695.One result was high outside the 2sd range.No sample was returned to product support, further investigation cannot be pursued.Unable to rule out sample specific interference as a potential cause for discrepant results.Reviewed the batch record for lot w60695.Lot met all cardiac tni/ckmb final release specifications.Customer stated the last qc sample run on lot w60695 was done on (b)(6) 2016 and testing was done on (b)(6) 2016.Per the package insert, good laboratory practice suggests that external controls should be tested with each new lot of test materials or every 30 days.This cannot be ruled out as a potential cause for discrepant results.Unable to determine root cause of complaint.No product deficiency was established.

Event Description

Report received of discrepant low tni x7 on customer's study between dxc 2, access 2 and triage meter for seven patients.No specific patient details reported only discrepant low triage values.No patient samples were available.According to customer "no samples were saved".(b)(6).No additional information provided.No reported adverse patient sequela.

Manufacturer Narrative

Investigation/conclusion: correction: customer's complaint of discrepant low was not replicated with in-house testing of retain lot w60695.No sample was returned to product support, further investigation cannot be pursued.Reviewed the batch record for lot w60695.Lot met all cardiac tni/ckmb final release specifications.Customer stated the last qc sample run on lot w60695 was done on (b)(6) 2016 and testing was done on (b)(6) 2016.Per the package insert, good laboratory practice suggests that external controls should be tested with each new lot of test materials or every 30 days.No product deficiency was established.

• Brand Name: KIT,TRIAGE, CARDIAC TNI / CKMB
• Type of Device: CARDIAC MARKER TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5987257
• MDR Text Key: 56004611
• Report Number: 2027969-2016-00634
• Device Sequence Number: 1
• Product Code: NBC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97022HS
• Device Lot Number: W60695RB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TRIAGE METERPRO DOMESTIC KIT SERIAL #(B)(4); TRIAGE METERPRO DOMESTIC KIT SERIAL #(B)(4)