MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TRIGL TRIGLYCERIDES TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL

Model Number C701

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

The customer stated that they received erroneous results for two samples from the same patient tested with triglycerides on a cobas 8000 c (701) module. The erroneous results were reported outside of the laboratory. The sick patient was at another hospital where trigl results were high (> 50 mmol/l). The patient was treated and the trigl results started to decrease. The patient was then moved to the customer site. The doctor wanted more specific results than > 50, so the lab performed a 1:10 dilution of the patient's samples. Results kept decreasing from 96 mmol/l to 81 mmol/l and then to 73 mmol/l. The customer was concerned with the complained samples since these samples initially resulted with low values which were not flagged. Samples tested after these affected samples had alarms which prompted the analyzer to automatically repeat them. The first complained sample from the patient initially resulted with a trigl value of 6. 44 mmol/l. The sample was diluted 1:10 and repeated, resulting with a trigl value of 61. 71 mmol/l. The sample was repeated without dilution, resulting with a trigl value of 3. 96 mmol/l. The sample result was corrected to > 50 mmol/l. The second complained sample from the patient initially resulted with a trigl value of 5. 25 mmol/l on (b)(6) 2018. The sample was diluted 1:5 and repeated, resulting with a trigl value of 38. 54 mmol/l on (b)(6) 2018. The sample result was corrected to 38. 54 mmol/l. No adverse events were alleged to have occurred with the patient. The trigl reagent lot number is 328103. The reagent expiration date was asked for, but not provided. Upon review of the alarm trace there were approximately 200 abnormal sample clot alarms occurring on different modules on the same line.

Manufacturer Narrative

The following medwatch fields have been updated: the patient has a known history of high triglyceride values. Base on review of the reaction monitor of the sample measurement, the specific root cause is most likely related to an extraordinarily high triglyceride concentration on the sample. This causes a depletion of oxygen which is needed for the color reaction this limitation is covered in product labeling.

• Brand Name: TRIGL TRIGLYCERIDES
• Type of Device: TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7939502
• MDR Text Key: 123961125
• Report Number: 1823260-2018-03449
• Device Sequence Number: 1
• Product Code: CDT
• Combination Product (y/n): N
• PMA/PMN Number: K873049
• 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: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: C701
• Device Catalogue Number: 05641489001
• Device Lot Number: 328103
• Was Device Available for Evaluation?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 10/05/2018 Patient Sequence Number: 1

Treatment

DEXAMETHASONE; PEG-ASPARAGINASE; VINCRISTINE