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 2018-03-20 for MPA 05005256002 manufactured by Roche Diagnostics.
[103282403]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103282404]
The customer complained of erroneous results for 1 patient sample from an aliquot generated by the customer's modular pre-analytics (mpa) system and tested for crep2 creatinine plus ver. 2 (crep2) on a cobas 6000 c (501) module. The erroneous result was reported outside of the laboratory. This medwatch will cover the mpa. Refer to medwatch with report number 1823260-2018-00256-00 for information on the c501 module. The initial crep2 result from an aliquot processed by the mpa was 12. 2 mg/dl. This result was reported outside of the laboratory. On (b)(6) 2018 the sample was repeated on the same c501 module and the result was 0. 6 mg/dl. The repeat result was believed to be correct. A new sample was obtained from the patient and the crep2 result was 0. 5 mg/dl. The customer looked at results from patient samples that were tested around the time of the event and did not identify any other questionable results. No adverse event occurred. The crep2 reagent lot number was 28332401 with an expiration date of 30-jun-2018. Investigation for the mpa is ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00877 |
| MDR Report Key | 7351819 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-03-20 |
| Date of Report | 2018-05-29 |
| Date of Event | 2018-01-12 |
| Date Mfgr Received | 2018-02-20 |
| Date Added to Maude | 2018-03-20 |
| 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 | MPA |
| Generic Name | AUTOMATED PREANALYTICAL SYSTEM |
| Product Code | CGX |
| Date Received | 2018-03-20 |
| Model Number | MPA |
| Catalog Number | 05005256002 |
| 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 | MPA |
| Generic Name | AUTOMATED PREANALYTICAL SYSTEM |
| Product Code | JQP |
| Date Received | 2018-03-20 |
| Model Number | MPA |
| Catalog Number | 05005256002 |
| 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 | 2018-03-20 |