MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-12-05 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[4014660]
The customer received questionable results for multiple assays for one patient sample and questionable ion selective electrode (ise) potassium results for five other patient samples. Of the data provided, only the results for the following three patient samples were discrepant and reported outside the laboratory. The samples were repeated on another cobas c501 analyzer. Patient sample 1 initial ion selective electrode (ise) sodium result was 134 mmol/l and the repeat result was 141 mmol/l. Initial potassium result was 3. 7 mmol/l and the repeat result was 2. 8 mmol/l. Initial ion selective electrode (ise) chloride result was 94 mmol/l and the repeat result was 110 mmol/l. Initial glucose result was 74 mg/dl and the repeat result was 51 mg/dl. Initial creatinine result was 8. 1 mg/dl and the repeat result was 4. 9 mg/dl. Initial total protein result was 6. 8 g/dl and the repeat result was 4. 6 g/dl. Initial albumin result was 3. 1 g/dl and the repeat result was 2. 2 g/dl. Initial total bilirubin result was 0. 3 mg/dl and the repeat result was 0. 9 mg/dl. Initial magnesium result was 2. 1mg/dl and the repeat result was 1. 4 mg/dl. Initial aspartate aminotransferase (ast) result was 10 u/l, the repeat result on the same cobas c501 was 500 u/l. The repeat result from the other cobas c501 analyzer was 506 u/l. Patient sample 2 initial potassium result was 3. 8 mmol/l and the repeat result was 4. 3 mmol/l. Patient sample 3 initial potassium result was 7. 8 mmol/l and the repeat result was 9. 1 mmol/l. All of the initial results were reported outside the laboratory. The repeat results from the other cobas c501 analyzer were believed to be correct and corrected reports were sent out. No patients were treated based on the erroneous results. Patient 1 was in the er and was discharged based in the initial results, but was called back when the physician saw the corrected results. The sodium, potassium and chloride electrode lot numbers were requested, but were not provided. The glucose reagent lot number was 68447901 with an expiration date of 09/30/2014. The creatinine reagent lot number was 68774301 with an expiration date 04/30/2014. The total protein reagent lot number was 68087901 with an expiration date of 06/30/2014. The albumin reagent lot number was 68120101 with an expiration date of 06/30/2014. The total bilirubin reagent lot number was 68579401 with an expiration date of 09/30/2014. The magnesium reagent lot number was 68696501 with an expiration date of 04/30/2015. The ast reagent lot number was 68315501 with an expiration date of 07/31/2014. The field service representative noted the customer found dried material around the reference electrode. He disassembled the is bath assembly and cleaned the cartridge area. He found the cell rinse nozzle spacer was missing on the nozzle and installed replacement spacer. The customer calibrated and ran qc successfully.
Patient Sequence No: 1, Text Type: D, B5
[11380825]
The investigation could not determine a specific root cause based on the provided information.
Patient Sequence No: 1, Text Type: N, H10
[11399506]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[11454676]
Additional information was received from the customer. Patient 1 was a (b)(6) year old male. Patient 2 was a (b)(6) year old male. Patient 3 was a (b)(6) year old female. Data for additional patient samples was received. Patient sample 4 was from a (b)(6) year old female. The initial potassium result was 3. 6 mmol/l and the repeat result was 4. 2 mmol/l. Patient sample 5 was from a (b)(6) year old female. The initial potassium result was 3. 5 mmol/l and the repeat result was 4. 0 mmol/l. Patient sample 6 was from a (b)(6) year old female. The initial potassium result was 3. 5 mmol/l and the repeat result was 4. 0 mmol/l.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-07433 |
| MDR Report Key | 3502278 |
| Report Source | 05,06 |
| Date Received | 2013-12-05 |
| Date of Report | 2013-12-26 |
| Date of Event | 2013-11-26 |
| Date Mfgr Received | 2013-11-26 |
| Date Added to Maude | 2013-12-05 |
| 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 | 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 Country | JA |
| 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 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | MZV |
| Date Received | 2013-12-05 |
| Model Number | NA |
| Catalog Number | 05860636001 |
| Lot Number | NA |
| ID Number | NA |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-05 |