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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: T2 BIOSYSTEMS, INC T2BACTERIA PANEL; DIRECT BLOOD BACTERIAL NUCLEIC ACID DETECTION SYSTEM
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T2 BIOSYSTEMS, INC T2BACTERIA PANEL; DIRECT BLOOD BACTERIAL NUCLEIC ACID DETECTION SYSTEM Back to Search Results
Model Number T2BACTERIA PANEL
Device Problem False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/24/2023
Event Type  malfunction  
Event Description
25 jul 2023: t2 bioystems received a customer complaint that the t2bacteria panel produced a discordant result on one patient.The t2bacteria panel produced a positive staphylococcus aureus result compared to a negative concurrent blood culture.
 
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Brand Name
T2BACTERIA PANEL
Type of Device
DIRECT BLOOD BACTERIAL NUCLEIC ACID DETECTION SYSTEM
Manufacturer (Section D)
T2 BIOSYSTEMS, INC
101 hartwell avenue
lexington MA 02421
Manufacturer (Section G)
T2 BIOSYSTEMS, INC
101 hartwell avenue
lexington MA 02421
Manufacturer Contact
scott blood
101 hartwell avenue
lexington, MA 02421
7814571206
MDR Report Key17602196
MDR Text Key321718840
Report Number3010097867-2023-00003
Device Sequence Number1
Product Code QBX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172708
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/23/2023
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
Device Operator Health Professional
Device Model NumberT2BACTERIA PANEL
Device Catalogue Number80-07342
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/25/2023
Initial Date FDA Received08/23/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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