MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-14 for COBAS 6000 CORE 04745868001 manufactured by Roche Diagnostics.
[2355613]
The user received analyzer alarms and a questionable urea (bun) result for one patient sample. The initial result was 56 mg/dl. Due to their laboratory protocol to repeat samples with delta failures they repeated the sample and the result was 113 mg/dl which was reported to the physician. The physician ordered the patient be sent to dialysis based on the 113 mg/dl result. The physician had a second sample drawn from the patient pre- dialysis and the result was 61 mg/dl and repeated at 60 mg/dl. Post dialysis a third sample was drawn and the result was 36 mg/dl and repeated as 34 mg/dl. The physician then questioned the 113 mg/dl result. The laboratory pulled the original sample and repeated it a third time with a result of 56 mg/dl. The user did not have access to information concerning the patient's current condition or if the patient was adversely affected. The bun reagent lot number was 64744301 with an expiration date of 04/30/2012. The user declined a service visit. A single falsely increased value of bun is no indication for dialysis. Testing of creatinine, calcium and bicarbonate would be recommended. Also, determination of central venous pressure to estimate the fluid overload and further diagnostics of the kidney would be recommended.
Patient Sequence No: 1, Text Type: D, B5
[9385324]
.
Patient Sequence No: 1, Text Type: N, H10
[9730736]
The investigation was not able to determine a specific root cause due to missing reaction kinetics. According to the alarm trace, three abnormal probe sucking flags were generated indicating either a problem with the sample probe itself or faulty pre-analytical procedure. The customer was advised to check the previous and following results, since the abnormal probe sucking flag might not be generated for each result depending on the degree of sample probe blockage. The decision to initiate dialysis in a patient with chronic kidney disease (ckd) or acute kidney disease (akd) involves the consideration of several clinical and laboratory parameters by the physician. Urea is not a stand alone parameter. It should be measured in combination with other laboratory parameters (e. G. Creatinine, electrolytes) and medical tests.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-06137 |
| MDR Report Key | 2335193 |
| Report Source | 05,06 |
| Date Received | 2011-11-14 |
| Date of Report | 2012-03-14 |
| Date of Event | 2011-10-19 |
| Date Mfgr Received | 2011-10-19 |
| Date Added to Maude | 2011-11-14 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 6000 CORE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CDS |
| Date Received | 2011-11-14 |
| Model Number | NA |
| Catalog Number | 04745868001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | MEDICAL TECHNOLOGIST |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-14 |