MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2010-02-23 for ANALYTICAL P MODULE 03261603001 manufactured by Roche Diagnostics.
[1437659]
The user received a discrepant calcium result for one patient sample. The initial result was 2. 68 mg/dl and was reported. On (b)(6) 2010, a request to repeat the calcium assay on the same sample was sent and results of 4. 38 and 4. 47 mg/dl were generated on another p module at the site. The sample was then repeated on the original analyzer and results of 4. 23 and 4. 38 mg/dl were generated. The patient received treatment for hypocalcaemia. No information was provided to determine if the patient was adversely affected. The calcium reagent lot was 617260. It was determined the sst serum sample tube was centrifuged for 7 minutes at 3000 rpms at 20 degrees c which was not in accordance with the tube manufacturer's specification.
Patient Sequence No: 1, Text Type: D, B5
[8450869]
Additional information concerning the patient was provided: "at admission to the er, the patient was on metformin 1000 mg bid, atorvastatin 10 mg daily, asa 325 mg daily, irbesartan 150 mg daily, tylenol#3 when needed, symbicort 200/6 inhaler as needed. " the patient received chemotherapy for his myeloma, but no specific information was provided.
Patient Sequence No: 1, Text Type: N, H10
[17022230]
The customer reported an issue with their meter. Upon investigation, the meter was found to exhibit the memory overwrite malfunction. There was no report of death or serious injury.
Patient Sequence No: 1, Text Type: D, B5
[17242998]
A specific root cause was not identifed. No problems were found with calibration, quality control, and precision recovery. Possible causes for the event include sample or reagent needle pipetting error, pre- analytical sample handling, and sample contamination.
Patient Sequence No: 1, Text Type: N, H10
[18113972]
The user received a discrepant calcium result for one patient sample. The initial result was 2. 68 mg/dl and was reported. On (b) (6) 2010, a request to repeat the calcium assay on the same sample was sent and results of 4. 38 and 4. 47 mg/dl were generated on another p module at the site. The sample was then repeated on the original analyzer and results of 4. 23 and 4. 38 mg/dl were generated. The patient received treatment for hypocalcaemia. No information was provided to determine if the patient was adversely affected. The calcium reagent lot was 617260. It was determined the sst serum sample tube was centrifuged for 7 minutes at 3000 rpms at 20 degrees c which was not in accordance with the tube manufacturer's specification.
Patient Sequence No: 1, Text Type: D, B5
[18212753]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-01169 |
| MDR Report Key | 1611625 |
| Report Source | 01,05,06 |
| Date Received | 2010-02-23 |
| Date of Report | 2010-07-09 |
| Date of Event | 2010-01-12 |
| Date Mfgr Received | 2010-01-29 |
| Date Added to Maude | 2010-07-09 |
| 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 ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| 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 | ANALYTICAL P MODULE |
| Generic Name | CLINCAL CHEMISTRY ANALYZER |
| Product Code | JFP |
| Date Received | 2010-02-23 |
| Model Number | NA |
| Catalog Number | 03261603001 |
| 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 | 2010-02-23 |