MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2015-08-14 for AMYL2 ALPHA-AMYLASE EPS VER.2 05167027190 manufactured by Roche Diagnostics.
[25145928]
(b)(6). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[25145929]
The customer complained of erroneous results for 1 patient tested for a- amylase eps ver. 2 (amyl2). Erroneous results were reported outside of the laboratory. The treating physician indicated that this patient undergoes routine blood tests regularly. In august 2014 the initial amyl2 result was 681 u/l. This result was reported outside of the laboratory. The repeat result from an external laboratory was 36 u/l. On (b)(6) 2015 the initial amyl2 result was 656 u/l. This result was reported outside of the laboratory. The repeat result from an external laboratory was 42 u/l. On (b)(6) 2015 the initial amyl2 result was 568 u/l and the patient was sent to the hospital. The patient was tested at the hospital with an amylase result of approximately 50 u/l and released. The (b)(6) 2015 sample was repeated in the customer's laboratory with an amyl2 result of 560 u/l. No adverse event occurred. The patient is in good condition. The amyl2 reagent lot was 611180 with an expiration date of 02/2016. Calibration and quality controls were acceptable. A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. A reagent issue can be excluded.
Patient Sequence No: 1, Text Type: D, B5
[56036508]
On (b)(6) 2016, the customer stated that they tested a new sample from the same patient for amyl2 on a c701 analyzer. This sample resulted with an amyl2 value of 585 u/l and the general practitioner was aware of this result. The result was said to be implausibly high. Last year, the patient was sent to the hospital where they found only physiological amyl2 values, but the patient did not show any signs of pancreatitis or illness. The patient was not adversely affected. The c701 analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[59392090]
A sample from the patient was provided for investigation. The high amyl2 result obtained by the customer could be reproduced and is considered to be correct. No turbidity was found in the patient sample, meaning that there is no unspecific interference caused by precipitation. The lipase value of the sample was found to be normal, indicating no inflammation of pancreatic cells. Gammopathy could also be excluded in the sample. All drugs the patient was taking are low dose drugs, so it is highly improbable that a drug interference is the root cause of the issue. The most likely root cause for the high amyl2 result is assumed to be measurement of macro-amylase.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03968 |
| MDR Report Key | 5004597 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-08-14 |
| Date of Report | 2015-08-14 |
| Date of Event | 2014-08-01 |
| Date Mfgr Received | 2015-07-27 |
| Date Added to Maude | 2015-08-14 |
| 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 |
| 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 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG), 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMYL2 ALPHA-AMYLASE EPS VER.2 |
| Generic Name | SACCHAROGENIC, AMYLASE |
| Product Code | CIJ |
| Date Received | 2015-08-14 |
| Model Number | NA |
| Catalog Number | 05167027190 |
| Lot Number | 138936 |
| 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 | 2015-08-14 |