MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-05-29 for VERIGENE GRAM-POSITIVE BLOOD CULTURE NUCLEIC 20-006-018 20-005-018 manufactured by Nanosphere Inc..
[5916139]
On (b)(6) 2015 sample (b)(6) was processed using the cartridge id (b)(4) verigene gram-positive blood culture nucleic acid test (bc-gp) on the verigene system. The result from the test was staphylococcus, s. Aureus, s. Epidermidis and mec a detected. The patient sample was also tested on maldi on (b)(6) 2015 and resulted as s. Hominis. The hosp facility notified nanosphere of the discrepancy between the bc-gp and maldi results on (b)(6) 2015. At that time nanosphere did not inquire if there was any adverse event to the patient; the hosp facility reported that the results had been released to a physician however they did not know if the therapy was altered and at the time no adverse event had been reported. Nanosphere again requested adverse event info on(b)(6) 2015. The hosp reported to nanosphere on (b)(6) 2015 only the bc-gp result of staphylococcus aureus was reported to the treating physician, and the patient was started on vancomycin therapy. The patient developed renal toxicity which may have been due to vancomycin, with multiple other factors involved in sickness, "hard to sort out".
Patient Sequence No: 1, Text Type: D, B5
[13341645]
The bc-gp is an in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection. Bc-gp is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria. A trained health care professional should interpret the results together with the patients medical history, clinical signs and symptoms, and the result of other diagnostic tests. During the course of nanosphere's investigation into the discrepancy the hosp sent a blood culture aliquot of the patient sample labeled as " (b)(6)" which was received by nanosphere on 02/18/2015. Nanosphere processed the sample on the bc-gp test and received a staphylococcus detected result on 04/13/2015 and also processed it on the vitek 2 resulting in staphylococcus hominis spp hominis. The initial result on (b)(6) 2015 of s. Aureus, s. Epidermidis and mec a detected, appears inaccurate, the expected result of only staphylococcus detected is expected for a staphylococcus hominis organism on the bc-gp test. The negative agreement for s. Epidermidis, s. Aureus, and meca are within the expected positive agreement confidence interval for the respective target per the verigene bc-gp package insert and no other reports of false positive have been reported with lot 120914018a. The investigation at nanosphere concluded that the false positive results observed on test (b)(4), was isolated to that individual test. The specific test cartridge id (b)(4) was unavailable for further investigation. Without a complete understanding of the patient medical history or time lines regarding treatment and therapy from hosp facility nanosphere has chosen to submit the mdr with limited understanding of the adverse event or role of the bc-gp test in the therapy decision.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006028115-2015-00001 |
| MDR Report Key | 4810601 |
| Report Source | 05,06 |
| Date Received | 2015-05-29 |
| Date of Report | 2015-05-05 |
| Date of Event | 2015-02-12 |
| Date Mfgr Received | 2015-05-05 |
| Device Manufacturer Date | 2014-12-01 |
| Date Added to Maude | 2015-06-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 4088 COMMERCIAL AVENUE |
| Manufacturer City | NORTHBROOK IL 60062 |
| Manufacturer Country | US |
| Manufacturer Postal | 60062 |
| Manufacturer Phone | 8474009000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERIGENE GRAM-POSITIVE BLOOD CULTURE NUCLEIC |
| Generic Name | BC-GP |
| Product Code | PAM |
| Date Received | 2015-05-29 |
| Model Number | 20-006-018 |
| Catalog Number | 20-005-018 |
| Lot Number | 120914018A |
| Device Expiration Date | 2015-06-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NANOSPHERE INC. |
| Manufacturer Address | 4088 COMMERCIAL AVENUE NORTHBROOK IL 60062 US 60062 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-05-29 |