MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-11 for GENT2 GENTAMICIN 04490843190 manufactured by Roche Diagnostics.
[130028092]
The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[130028093]
A customer in ()b)(6) complained that the trough reference ranges listed in the gent2 gentamicin (ivd) package insert is not accurate and that it led to the renal failure of 2 patients. The date of the event is only an approximation. Patient 1 was covered in medwatch with patient identifier (b)(6). No specific data has been provided for patient 2. The customer could only make the following statement in reference to patient 2 "reference values?? Recommended by roche did not allow some of our practitioner to make a good therapeutic adjustments for gentamicin. Two patients had for several days residual levels above the recommendations, leading to renal failure with gentamicin (fortunately no ototoxicity in both cases). These renal insufficiencies due to gentamicin were confirmed by renal biopsies that showed gentamicin deposits. " the customer stated the gent2 results obtained from the device were accurate. The us department of health and human services (us hhs), national institutes of health (nih), health resources and services administration (hrsa), and us cdc recommendations: patients should be treated in consultation with an infectious disease specialist. Roche labeling is aligned with the gentamicin package insert for gentamicin sulfate for injection. Roche product labeling for gent2 states the disclaimers: "each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges. Although optimum values may vary, peak serum values in the range of 6 to 10? G/ml (12. 5 to 20. 9? Mol/l) and trough values in the range of 0. 5 to 2. 0? G/ml (1. 0 to 4. 2? Mol/l) are generally accepted for therapeutic effectiveness. The achievement of non-toxic, but therapeutic, serum levels is often difficult, even in patients with normal renal function. Complications encountered with the use of gentamicin are ototoxicity and nephrotoxicity. However, these reactions are predictable, and close patient monitoring is essential for the successful use of this agent. " "when monitoring gentamicin trough concentrations, dosage should be adjusted so that levels above 2 mcg/ml are avoided". "nephrotoxicity is a known side effect of gentamicin". From the black box warning on the gentamicin injection usp package insert: "concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs, such as cisplatin, cephaloridine, kanamycin, amikacin, neomycin, polymyxin b, colistin, paromomycin, streptomycin, tobramycin, vancomycin, and viomycin, should be avoided. " the boxed warning also states: "when monitoring gentamicin trough concentrations, dosage should be adjusted so that levels above 2 mcg/ml are avoided. " additional information about the patient's current condition along with information has been requested but have not been provided. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-04792 |
| MDR Report Key | 8152382 |
| Date Received | 2018-12-11 |
| Date of Report | 2019-01-22 |
| Date of Event | 2018-10-05 |
| Date Mfgr Received | 2018-11-13 |
| Date Added to Maude | 2018-12-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GENT2 GENTAMICIN |
| Generic Name | ENZYME IMMUNOASSAY, GENTAMICIN |
| Product Code | LCD |
| Date Received | 2018-12-11 |
| Model Number | NA |
| Catalog Number | 04490843190 |
| Lot Number | 35283701 |
| Device Expiration Date | 2019-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2018-12-11 |