MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-06-07 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[77307075]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[77307076]
The customer complained of multiple sample up/down alarms and an erroneous low result for 1 patient tested for phos2 phosphate (inorganic) ver. 2 (phos2) on a cobas 6000 c (501) module. The initial phos2 result was 0. 1 mg/dl with a data flag. The lab tech was not paying close attention and reported the result outside of the laboratory. The sample was repeated on a different analyzer and the result was 4. 2 mg/dl. The repeat result was believed to be correct and a corrected report was issued. The patient was treated with phosphorus based on the initial phos2 result reported outside of the laboratory. There was no allegation that an adverse event occurred due to this treatment. The customer stated there were other erroneous results reported outside of the laboratory. The customer did not have the specific results, however, the repeat results were not deemed to be clinically significant when compared to the results initially reported outside of the laboratory. The only clinically significant result the customer had was the low, erroneous phos2 result. The phos2 reagent lot number was 19635201 with an expiration date of 01/31/2018. The customer checked the sample probe and found that there was gel in it. The customer does not have another probe so she will clean the probe. The field service engineer visited the customer site after the customer had cleaned the sample probe. The fse ran a pipetting accuracy check. The customer ran quality controls. The results from all instrument tests were acceptable.
Patient Sequence No: 1, Text Type: D, B5
[115209758]
The investigation determined that the root cause of the issue was the gel on the sample probe that the operator found.
Patient Sequence No: 1, Text Type: N, H10
[118808749]
Medical assessment of the event was performed and noted that the initial phos2 result was accompanied by a data flag and should not have been reported outside of the laboratory. The decision to treat the patient after one questionable, plausible result could not be addressed as the medical background of the patient is not known (e. G. Kidney disease, patient in intensive care unit). A product problem was not identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01167 |
| MDR Report Key | 6619626 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-07 |
| Date of Report | 2017-07-11 |
| Date of Event | 2017-05-10 |
| Date Mfgr Received | 2017-05-11 |
| Date Added to Maude | 2017-06-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 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 | CEO |
| Date Received | 2017-06-07 |
| Model Number | C501 |
| 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 | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Brand Name | COBAS 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-07 |
| Model Number | C501 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-07 |