MalfunctionQBX

T2BACTERIA PANEL

Received Dec 6, 2024 · Event occurred Oct 27, 2024

Report 3010097867-2024-00031 · MDR key 20867792

Device

Generic name

Direct Blood Bacterial Nucleic Acid Detection System

Manufacturer

T2 Biosystems, Inc.

Model number

T2BACTERIA PANEL

Catalog number

80-08072

Lot number

WO-36108

Product problems

False Negative Result
False Negative Result

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

INSTRUMENT HAD MULTIPLE HARDWARE FAILURES LEADING TO ERRORS AND INVALID RESULTS. T2 SERVICE ENGINEER HAS REPLACED FAULTY HARDWARE AND IS IN THE PROCESS OF TESTING THE INSTRUMENT.

Description of Event or Problem

7 NOVEMBER 2024: T2BIOSYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A SUSPECTED CLINICAL FALSE NEGATIVE E. COLI RESULT USING THE T2BACTERIA PANEL.