MTD TEST * 1001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-10-25 for MTD TEST * 1001 manufactured by Gen-probe, Inc..

Event Text Entries

[16612479] Three hiv-infected pts seen in rptr's institution with abnormal chest radiographs and fluorochrome stain-positve sputum were evaluated for tuberculosis, including performance of the test on expectorated sputum samples. Two of three pts' sputa were highly smear-positive (i. E. >100 bacilli/high power field), while the third pt's sputum contained 6-10 bacilli/hpf. Results on the initial specimens from these pts ranged from 43,498 to 193,858 rlu. Mfr defines values >_ 30,000 rlu as indicative of positive test, i. E. , the presence of m. Tuberculosis rna. All three pts' sputum cultures yielded growth of m. Kansasii within 6-12 days. One pt's culture also contained m. Avium, but none of the initial or follow-up cultures from the pts revealed m. Tuberculosis. However, subsequent cultures from all three pts again revealed m. Kansasii. Other sputum specimens from two of the pts that had only 1+ or 2+ smear positivity were test-negative in 2/3 instances. A fourth pt with 1+ smear positive sputum due to m. Kansasii yielded a negative test. Five cultures of m. Kansasii (including these 4 pts' isolate and cultures of several other species were examined at densities of test. All five isolates of m. Kansasii and 3/3 isolates of m. Simiae yielded false-positive tests with rlu values of 75,191 to 335,591. These results indicate that low-level false-positive results can occur due to m. Kansasii and possibly other mycobacterium species in sputum. Rlu values of 30,000-400,000 should be interpreted with caution. Add'l pts's ages: 40, 44. Add'l dates of event: 4/4/96, 4/5/96.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1010157
MDR Report Key44774
Date Received1996-10-25
Date of Report1996-10-17
Date of Event1996-03-28
Date Added to Maude1996-10-29
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMTD TEST
Generic NameANTI-SERUM, FLUORESCENT, MYCOBACTERIUM TUBERCULOSIS
Product CodeGRT
Date Received1996-10-25
Model Number*
Catalog Number1001
Lot Number103477, 602050
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key45685
ManufacturerGEN-PROBE, INC.
Manufacturer Address9880 CAMPUS POINT DR SAN DIEGO CA 921211589 US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 1996-10-25

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