[126070140]
The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[126070141]
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. Only the patient information and the gent2 results from a cobas 8000 cobas c 502 module (serial number (b)(4)) were provided for 1 patient. Information and details about the other patient involved has been requested but has not yet been provided. Patient 1 was initially hospitalized in (b)(6) and treated with both gentamicin and vancomycin by a cardiologist for bartonella endocarditis. The gent2 trough results from the cobas c502 were as follows: (b)(6). The customer stated the gent2 results obtained from the device were accurate. The cardiologist, using both the published trough reference range of 0. 5 - 2 ug/ml and the baseline renal function values obtained for the patient, continued treatment at the same dosage. At the end of (b)(6), the patient presented with signs of kidney failure and then was referred to the infectious disease department. A renal biopsy was performed that confirmed a gentamicin renal failure. Gentamicin treatment was stopped until the patient's trough was below 0. 5 ug/ml. The us department of health and human services (us hhs), national institutes of health (nih), (b)(4): 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 ug/ml (12. 5 to 20. 9 umol/l) and trough values in the range of 0. 5 to 2. 0 ug/ml (1. 0 to 4. 2 umol/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 about patient 2 has been requested but have not been provided. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5