MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE CARDIAC TROP T; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Catalog Number 07007302190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer stated that they received erroneous results for one patient sample tested for roche cardiac poc troponin t (tnt) on a cobas h232 instrument with serial number (b)(4).The cobas h 232 instrument is not released for distribution in the united states, nor is it like or similar to a product released for distribution in the united states.The sample was tested at 17:12, resulting as 390 ng/l.The sample was repeated at 17:30, resulting as 270 ng/l.No adverse events were alleged to have occurred with the patient.The customer's product was requested for investigation.Relevant retention tnt test strip material of lot 296797 was measured on a qualified cobas h232 with three spiked blood samples (c=260 ng/l, c=340 ng/l and c=400 ng/l).Each blood sample was measured with three test strips.Results of measurements on a qualified cobas h232: first spiked blood sample (c=260 ng/l): first measurement :251 ng/l , second measurement: 259 ng/l, third measurement: 258 ng/l.Second spiked blood sample (c=340 ng/l): first measurement :330 ng/l , second measurement: 329 ng/l, third measurement: 332 ng/l.Third spiked blood sample (c=400 ng/l): first measurement :390 ng/l , second measurement: 389 ng/l, third measurement: 387 ng/l.The results of all measurements fulfill requirements.

Manufacturer Narrative

The customer's cobas h232 analyzer was provided for investigation.No abnormalities were seen with the analyzer upon visual check.Relevant retention tnt test strip material of lot 296797 was measured on a the returned cobas h232 analyzer with two spiked blood samples (c= approximately 300 ng/l).The same samples were also measured on a qualified cobas h232 analyzer using the master lot of test strip material.Each blood sample was measured with three test strips.Results: measurements on customer cobas h232 with retention samples of lot 296797-- first spiked blood sample (c= approximately 300 ng/l): first measurement = 261 ng/l , second measurement = 300 ng/l, third measurement = 263 ng/l.Second spiked blood sample (c= approximately 300 ng/l): first measurement = 247 ng/l , second measurement = 300 ng/l , third measurement = 254 ng/l.Measurements on qualified cobas h232 with master lot 28237880 first spiked blood sample (c=approx.300 ng/l): first measurement = 303 ng/l, second measurement = 263 ng/l, third measurement = 322 ng/l.Second spiked blood sample (c=approx.300 ng/l): first measurement = 320 ng/l, second measurement = 279 ng/l, third measurement = 275 ng/l.The results of all measurements fulfill requirements.

• Brand Name: ROCHE CARDIAC TROP T
• Type of Device: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7569939
• MDR Text Key: 110193237
• Report Number: 1823260-2018-01749
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• PMA/PMN Number: K964372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 07007302190
• Device Lot Number: 29679711
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR